Introduction

F1000Research

2046-1402

F1000 Research Limited

London, UK

10.12688/f1000research.139742.1

Research Article

Articles

Effect of fluticasone-impregnated throat packs on postoperative sore throat (POST) and hoarseness of voice: A randomized clinical trial

[version 1; peer review: 1 approved, 2 approved with reservations]

Talapatra

Arjun

Data Curation Formal Analysis Investigation Methodology Writing – Original Draft Preparation https://orcid.org/0009-0007-3463-5708 1 Mathew

Shaji

Conceptualization Data Curation Project Administration Resources Supervision Validation Visualization 1 Kanakalakshmi

Sushma Thimmaiah

Conceptualization Project Administration Software Supervision Validation Visualization Writing – Review & Editing https://orcid.org/0000-0002-4460-4020 a 1 Rani

Rama

Project Administration Software Supervision Validation Writing – Review & Editing https://orcid.org/0000-0001-6291-8544 1 1Department of Anaesthesiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India

a sushma.tk@manipal.edu

No competing interests were disclosed.

17 10 2023

2023

1352

9 8 2023

2023

This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background: Post-operative sore throat (POST) is one of the most common complaints post-endotracheal intubation and can be decreased through various interventions. This study aimed to determine the effect of fluticasone-impregnated versus saline throat packs on the occurrence and severity of POST and voice hoarseness.

Methods: This prospective, randomized, double-blinded trial was conducted on patients undergoing nasosinus surgeries at Kasturba Medical College and Hospital. Patients were randomized to groups based on a computer-generated table of random numbers post-intubation after placing a definite length of oropharyngeal packs into group F (fluticasone) who received four puffs of fluticasone furoate-soaked throat packs and group C (control) wherein normal saline-soaked throat packs were used. Determining the incidence of POST and voice hoarseness was the primary outcome; severity of POST and voice hoarseness, patient satisfaction scores at 24 hours post-surgery and adverse events were secondary outcomes.

Results: Overall, 86 patients were randomized and 43 patients were included in each group. Incidence of POST (%) and voice hoarseness (%) were 55.8, 55.6, 55.8, 53.4 and 30.2, 28, 28, 28 in group C. Incidence of POST (%) and voice hoarseness (%) were 37.2, 37.2, 37.2, 34.8 and 14, 14, 14,14 in group F at 1, 2, 6 and 24 hours, respectively, however, the p values were not found to be significant at any time interval. There was no significant difference in terms of severity of POST and voice hoarseness, patient satisfaction scores between the groups and there were no reported adverse events.

Conclusions: In patients undergoing nasosinus surgery under general anesthesia with endotracheal intubation, fluticasone furoate-impregnated throat packs failed to show any significant reduction in the incidence and severity of POST as well as hoarseness of voice, and even though it was not statistically significant, the fluticasone impregnated group had higher patient satisfaction scores.

Registration: CTRI ( CTRI/2020/09/027946; 22/09/2020).

Endotracheal intubation Fluticasone furoate Hoarseness of voice Nasosinus surgeries Postoperative sore throat

The author(s) declared that no grants were involved in supporting this work.

Introduction

Tracheal intubation is mostly performed under general anesthesia to secure the airway and is usually associated with variable degrees of trauma. Postoperative sore throat (POST), which ranges from 12.1% to 70%, is one of the commonest consequences of intubation, while hoarseness of voice varies from 4–43%. ¹ ^– ³ The eighth worst possible post-anesthesia effect is POST, which imparts a strongly negative influence on the overall experience of surgery and stay in the hospital postoperatively. ⁴ POST is caused by a number of different factors, including vocal cord damage, congestive blood loss, and damage to the epithelium and mucosal cells caused by airway secretion. ⁵ In recent years, it has been reported that the shape of tracheal tubes, the size of the cuffs, the endotracheal intubation technique, the cuff pressure, and the use of inhalation anesthesia as contributing factors to POST. ⁶ ^– ¹¹

Many surgical subspecialties use throat packs for various reasons. During surgery, they gather blood, secretions, and bone and cartilage fragments. It is asserted that doing so will lessen their inhalation and swallowing after surgery, which will lessen the likelihood of postoperative complications. ¹² Even though there are several advantages of inserting throat packs there are certain drawbacks and POST is major among them. ¹³

To reduce the frequency of POST, many interventions can be used, including the use of compact tracheal tubes, ¹⁴ using video laryngoscopy during intubation, ¹⁵ limiting endotracheal cuff pressure, ¹⁶ using steroids during surgery, ¹⁷ ^– ¹⁹ topically applying non-steroidal anti-inflammatory drugs (NSAIDs), ²⁰ or using different gargles (magnesium and ketamine) during surgery. ²¹

The topical administration of nonsteroidal anti-inflammatory drugs, lidocaine, steroids, N-methyl-d-aspartate receptor antagonists, and Glycyrrhiza have all been used to prevent POST through various mechanisms of action, according to systematic reviews. ²² However, a thorough search of the literature showed no evidence of studies involving the use of throat packs soaked with steroid sprays. ²³ Our study drug, fluticasone furoate is typically available as a nasal spray and studies have not shown any adverse effects associated with the application of this spray. Therefore, the specific objectives of our study was to determine the effect of fluticasone-impregnated throat packs versus saline throat packs on the incidence and severity of POST and hoarseness of voice as well as to assess patient satisfaction at 24 hours in the postoperative period and any adverse events.

Methods Ethical approval

This clinical trial received approval from the Institutional Ethics Committee (Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee (IEC no: 714/2019, dated 18/09/2019) and was registered with the Clinical Trials Registry - India (CTRI; Registration no: CTRI/2020/09/027946; 22/09/2020). Patients provided written informed consent.

Trial design

Between September 2020 and July 2021, patients scheduled for nasosinus surgeries under general anesthesia with endotracheal intubation at Kasturba Medical College and Hospital participated in this prospective, 1:1 randomized, double-blinded clinical trial. After receiving approval from the Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee and registering with the CTRI, 86 patients were enrolled using the inclusion and exclusion criteria after providing written informed consent without any deviation from the original trial protocol and the trial was conducted according to the principles expressed in the Declaration of Helsinki. This study adheres to the CONSORT guidelines, and the proforma, model consent form and protocol can be found as Extended data. ³⁹

Participants

Participants classified as I or II according to the American Society of Anaesthesiologists (ASA) physical status classification, patients aged 18–60 years of both sexes were included in the study. Whereas those with a pre-existing sore throat and/or hoarseness of voice, anticipated difficult airway, already on steroids, requiring more than two attempts at endotracheal intubation and trauma during intubation were excluded.

Simple randomization with a 1:1 allocation ratio was carried out using an online randomization service. After patients had finished all baseline assessments and observer one had been blinded, sequentially numbered, opaque, and sealed envelopes were opened to reveal the allocation sequence.

Interventions

Patient preparation: On the morning of operation, all patients were given tab ranitidine 150 mg and tab metoclopramide 10 mg. Nil per oral orders of 6 hours for solids and 2 hours for clear fluids was advised. The patient was identified on the day of surgery, fasting status was confirmed and they were shifted to the operating room. The monitors included a 5-electrode ECG, a non-invasive blood pressure monitor, and a pulse oximeter before induction of anaesthesia. Baseline blood pressure, heart rate and peripheral oxygen saturation were noted. The intravenous line was secured with a suitable gauge intravenous catheter under aseptic precautions, and the Ringer’s lactate infusion was started.

All the patients were pre-oxygenated for 3 minutes with 100% oxygen before being induced with intravenous 2 μg/kg fentanyl, induction with 2-3 mg/kg propofol, and neuromuscular blockade (NMB) with 0.1 mg/kg vecuronium. When the train-of-four count was zero, the patient was intubated under direct laryngoscopy (7 mm tube for females and 8 mm tube for males), which was inflated with air to a pressure of 25 mmHg. The demographic characteristics in terms of age, sex, BMI, smoking history and the mean duration of surgery were analyzed.

Observer one performed a preoperative evaluation and obtained informed consent. He was blinded to the group the patient was allotted. Additionally, he evaluated the patient after surgery and recorded the occurrence and severity of POST, voice hoarseness, and patient satisfaction score based on a predetermined score. Observer two performed the intubation and intervention according to the group allotted. Based on the group allocated, the patient received the throat pack soaked with either four puffs (400 mcg) of fluticasone furoate spray for group F and normal saline for group C. With the aid of Magill’s forceps and direct laryngoscopy, packs with standard dimensions of 120 cm × 7.5 cm were inserted. The use of steroids was avoided intraoperatively. Anesthesia was maintained with isoflurane, 40% oxygen and 60% air. Cuff pressure was kept below 25 cm H ₂O throughout the operation. In the end, the anesthetic agents were tapered and stopped, and 0.05 mg/kg of neostigmine was used to counter residual NMB. None of the patients received glycopyrrolate preoperatively or during the procedure. The throat pack was removed under direct laryngoscopy once the surgery was completed after gentle oral suctioning. Once the extubation criteria were satisfied, the patient was extubated and moved to the postoperative recovery room.

Parameters assessed

•

Age, sex, BMI, smoking history and the mean duration of surgery were documented.

•

Post-operative sore throat at 1 hour, 2 hours, 6 hours and 24 hours using a 4-point scale.

•

Hoarseness of voice at 1 hour, 6 hours and 24 hours using a 4-point scale.

•

Patient satisfaction score at 24 hours in the postoperative period.

Observer 1 interviewed patients at 1, 2, 6, and 24 hours to assess the incidence and severity of postoperative sore throat and hoarseness of voice, patient satisfaction level as well as any adverse events.

Postoperative assessment

The post-operative sore throat severity ¹⁸ was graded as follows: i) Grade 0, no sore throat at any time since the operation; ii) Grade 1, no pain, only discomfort or itchy sensation in the throat; iii) Grade 2, pain on swallowing or attempt at swallowing; and iv) Grade 3, pain at rest.

The severity of the hoarseness of voice ¹⁹ was graded as follows: i) Grade 0, no evidence of hoarseness of voice at any time since the operation; ii) Grade 1, no evidence of hoarseness at the time of the interview; iii) Grade 2, hoarseness at the time of interview noted by the patient only; and iv) Grade 3, hoarseness that is easily noted by the assessor at the time of the interview.

Patient satisfaction score was graded as follows: i) Score 0, poor; ii) Score 1, fair; iii) Score 2, good; and iv) Score 3, excellent.

Outcomes

The primary outcome analyzed was the incidence of POST and post-operative voice hoarseness at 1, 2, 6 and 24 hours in both group C and group F. The secondary outcomes analyzed were severity of POST and voice hoarseness at 1, 2, 6 and 24 hours in both the groups including patient satisfaction scores at 24 hours post-surgery and any adverse events.

Blinding

Observer one was the principal investigator who did the preoperative evaluation, after checking suitability for inclusion criteria in the study and obtaining written informed consent. He was blinded to the group the patient was allotted. He explained to the patient about the study and assessed the patient postoperatively on their grade of postoperative sore throat, hoarseness of voice and patient satisfaction score according to a pre-existing scoring scale.

Observer two was the Consultant anaesthesiologist, who performed the laryngoscopy and intubation and performed the intervention according to the group allotted.

Statistical analysis

A pilot study with 10 patients in each group revealed that the control group had a 60% incidence of POST and the experimental group had a 40% incidence, which was used to determine the sample size. We required 96 patients in each group with a 20% difference between the two groups, assuming 85% power and a 5% level of significance. However, given the ongoing COVID-19 pandemic, due to a drastic reduction in the number of elective nasosinus surgeries in our institute, we were able to conduct our trial only in 86 patients (43 per group), despite extending our study period for three more months. For continuous variables, the data were presented as mean, and for categorical variables, as a percentage of frequency. To analyze significant differences between dichotomous variables, the chi-squared test was used. The term “p-value <0.05” denoted a statistically significant result. IBM SPSS Statistics (RRID:SCR_016479) 20.0 for Windows (SPSS Inc., Chicago, IL, US), a statistical software program, was used to conduct the statistical analysis.

Results

A total of 106 ASA I–II patients were screened in our study of which only 86 patients were included in our study. Of the 20 excluded, 11 patients required repeated attempts for intubation while nine required airway adjuncts ( Figure 1).

Figure 1. CONSORT diagram.

Group C, Control group; Group F, Fluticasone group.

There were 43 patients in each group and their demographic characteristics were comparable with no significant difference in terms of age, sex, and smoking history. The majority of patients in either group had ASA physical status II. The mean duration of surgery among both groups was also similar ( Table 1).

Table 1. Baseline characteristics.

Characteristics	Group C (Mean ± SD) (n=43)	Group F (Mean ± SD) (n=43)	p-value
Age (in years)	29.2 ± 3.9	29.8 ± 3.5	0.52
Female participants	25	26	0.43
BMI (kg/m ² )	27.4 ± 3.9	26.4 ± 2.9	0.3
Smoking history	13	15	0.63
Duration of surgery (hours)	2.3 ± 0.3	2.4. ± 0.3	0.92

Group C, control group; Group F, Fluticasone group; SD, Standard deviation; BMI, body mass index.

Recruitment

Primary outcome

Incidences of postoperative sore throat were 55.8, 55.6, 55.8 and 53.4% in group C at 1, 2, 6 and 24 hours and 37.2, 37.2, 37.2 and 34.8% in group F at 1, 2, 6 and 24 hours, respectively ( Table 2, Figure 2). Incidences of postoperative hoarseness of voice were found to be 30.2, 28.0, 28.0 and 28.0% in group C at 1, 2, 6 and 24 hours and 14.0, 14.0, 14.0 and 14.0% in the group F at 1, 2, 6 and 24 hours, respectively ( Table 2, Figure 3). Although there was a lower incidence of POST and hoarseness of voice in the fluticasone group at 1, 2, 6 and 24 hours, the p values were not found to be significant at any time interval.

Table 2. Primary outcomes.

Time interval (in hours)	Incidence of POST		p-value	Incidence of postoperative hoarseness of voice		p-value
Time interval (in hours)	Group C (n=43) (n, % (95% CI))	Group F (n=43) (n, % (95% CI))	p-value	Group C (n=43) (n, % (95% CI))	Group F (n=43) (n, % (95% CI))	p-value
1	24 (55.8%) (0.411, 0.695)	16 (37.2%) (0.243, 0.521)	0.52	13 (30.2%) (0.185, 0.452)	6 (14%) (0.061, 0.276)	0.11
2	24 (55.8%) (0.411, 0.695)	16 (37.2%) (0.243, 0.521)	0.52	12 (28%) (0.185, 0.452)	6 (14%) (0.061, 0.276)	0.18
6	24 (55.8%) (0.411, 0.695)	16 (37.2%) (0.243, 0.521)	0.52	12 (28%) (0.185, 0.452)	6 (14%) (0.061, 0.276)	0.18
24	23 (53.4%) (0.389, 0.674)	15 (34.8%) (0.223, 0.498)	0.12	12 (28%) (0.185, 0.452)	6 (14%) (0.061, 0.276)	0.18

POST, Post-operative sore throat; Group C, Control group; Group F, Fluticasone group; CI, Confidence interval.

Figure 2. Incidence of POST.

POST, postoperative sore throat.

Figure 3. Incidence of postoperative hoarseness of voice. Secondary outcomes

According to the criteria outlined in the methodology, the degree of POST and hoarseness of voice were graded.

Grade 0 sore throats were present in 20 patients in group F (46.5%) and 28 patients in group C (65.1%). Grade 1 sore throats were present in 14 patients in group C (32.5%), 10 patients in group F (23.2%), and seven patients in group C (16.2%) and five patients in group F (11.6%). At 24 hours after surgery, only two patients in group C (4.6%) and none of the patients in group F had grade 3 sore throats. Nevertheless, there was no statistically significant difference between the groups ( Table 3).

Table 3. Secondary outcomes.

Grading of severity at 24 hours	Severity of POST		p-value	Severity of postoperative hoarseness of voice		p-value
Grading of severity at 24 hours	Group C (n=43) (n, % (95% CI))	Group F (n=43) (n, % (95% CI))	p-value	Group C (n=43) (n, % (95% CI))	Group F (n=43) (n, % (95% CI))	p-value
0	28 (65.1%) (0.501, 0.776)	20 (46.5%) (0.325, 0.610)	0.072	23 (53.4%) (0.389, 0.674)	18 (41.8%) (0.283, 0.566)	0.099
1	14 (32.5%) (0.204, 0.475)	10 (23.2%) (0.129, 0.379)		10 (23.2%) (0.129, 0.379)	9 (20.9%) (0.112, 0.354)
2	7 (16.2%) (0.078, 0.302)	5 (11.6%) (0.046, 0.249)		14 (32.5%) (0.204, 0.475)	10 (23.2%) (0.129, 0.379)
3	2 (4.6%) (0.004, 0.163)	0		1 (2.3%) (0.0001, 0.131)	1 (2.3%) (0.0001, 0.131)

POST, Post-operative sore throat; Group C, Control group; Group F, Fluticasone group; CI, Confidence interval.

A total of 23 patients in group C (53.4%) and 18 patients in group F (41.8%) both experienced grade 0 hoarseness of the voice. Grade 1 was present in 10 patients in group C (23.2%) and nine patients in group F (20.9%). Grade 2 hoarseness of voice affected 14 patients in group C (32.5%) and 10 patients in group F (23.2%). At 24 hours after surgery, there was one patient in group C (2.3%) and one patient in group F (2.3%) who both had grade 3 hoarseness of voice. The difference between the groups was present, but it was not statistically significant ( Table 3).

Most of the patients in both groups had excellent patient satisfaction scores, however, patients in group F had higher satisfaction scores 24 hours postoperatively but were not statistically significant ( Table 4).

Table 4. Patient satisfaction score at 24 hours.

Score	Group C (n = 43)	Group F (n = 43)	P-value
0	6	2	0.072
1	7	6
2	9	6
3	21	29

Group C, Control group; Group F, Fluticasone group.

Adverse events

Neither group experienced any adverse effects.

Discussion

Endotracheal intubation is the most definitive way of securing the airway. Many anesthesiologists consider POST, a frequent anesthetic complication, to be a minor complication. However, for some patients, it might be their initial complaint as soon as they regain consciousness, hence reduction of POST enhances postoperative patient comfort, satisfaction and overall hospital stay. ²⁴

Throat packs are used in oronasal procedures mainly to prevent intraoperative aspiration of blood into the respiratory and digestive tract. It is common knowledge that using pharyngeal packs makes recovery from surgery more painful and uncomfortable. POST brought on by oropharyngeal packs is unclear. It is postulated that the hard, abrasive cotton fibers of the pack can cause dryness of the surrounding tissues as well as the instrumentation per se can cause local inflammation eventually leading to POST and hoarseness of voice. ²⁵ Even though various pharmacological modalities of attenuating POST have been studied in the past ¹⁴ ^– ²¹ there is no extensive literature documenting the use of steroid-impregnated throat packs. Since steroids have an anti-inflammatory effect, we analyzed their effect in mitigating POST and hoarseness of voice.

In prior studies, patient factors predicting POST included young age, being female and having a smoking history. ²⁶ ^, ²⁷ Lautenbacher et al., ²⁸ and Petrini et al., ²⁹ revealed that older patients when compared to the younger age group had a lesser response to pain stimulus as ageing reduces pain sensitivity and intensity, thus suggesting young age as a predictor of POST. However, in our study, we found no difference among the groups as the majority of the patients in both groups were young. According to Feine et al., ³⁰ women are more sensitive to the intensity of the pain and men typically have higher pain tolerance thresholds ²⁸ suggesting that female patients tend to have a higher incidence of POST. Similar to the study by Jaensson et al., ³¹ who found no appreciable difference in POST incidence between men and women, there is no effect of sex on POST and hoarseness of voice in this study. Smoking is a significant predictor because it is known to cause airway inflammation on its own, ³² ^, ³³ which contributes to POST, however, due to the small sample size in this study, we were unable to detect any influence on POST, which is similar to the study by Lee et al. ³⁴

In the study by Higgins et al., ² he found that the incidence of POST was higher in those with ASA physical status III when compared to those with ASA I/II (p≤0.05), however in our study all the patients had ASA status of I/II, thus no difference could be recorded. Longer surgery times have been shown in earlier studies ³⁵ ^, ³⁶ to affect the occurrence of POST, with factors including surgical manipulation of the airway and surrounding tissue, repeated suctioning, high anesthetic gas flow rates, and lack of airway humidity as contributors. However, in our study, there was no such difference because all of the patients were posted for nasosinus surgery and the surgical times in the two groups were comparable.

The overall incidence of POST and hoarseness of voice in our study was similar to the study done in 2017 on Korean patients by Lee et al., ³⁴ wherein 207 patients were analyzed, among whom 119 patients (57.5%) developed POST and 80 patients (38.6%) developed hoarseness of voice. However, many prior studies have shown that the incidence of POST may be up to 70% and that of hoarseness is reported to range from 4–43%. ¹ ^– ⁴ Even though the incidence of POST and hoarseness of voice was lower in the fluticasone group than in the control group in this study, there was never a postoperative difference that was statistically significant. This study is comparable to one by Park SY et al., ³⁷ which compared the incidence of POST in patients with tracheal tubes impregnated with triamcinolone acetonide (n=72) and chlorhexidine (n=72) during intubation. His research demonstrated that when compared to the chlorhexidine group (71.8%; 51/72) the incidence of POST was significantly lower in the steroid-impregnated group (19.4%; 14/72) (p<0.001).

The overall severity of POST as well as hoarseness of voice was lower fluticasone group but was not statistically significant. These results are similar to the study by Park SY et al., ³⁷ wherein the severity of POST was analyzed at 1, 6 and 24 hours and found that among 72 patients in the steroid-soaked throat pack group majority (68/72) had grade 0 severity at 1 hour and 24 hours and very few (10/72) had grade 1 severity of POST, which is similar to our study, however, their study revealed significant difference (p<0.001), which is unlike our study and probably can be explained by the small sample size in each group.

The majority of patients in this study reported positive experiences with fluticasone-impregnated throat packs when compared to the placebo group, but the findings were not statistically significant. The analysis of POST in 140 patients who needed intubation by Macintosh laryngoscope versus GlideScope in the study by Aqil M et al., ³⁸ also included patient satisfaction scores at 24 hours following surgery, which was similar to our study.

Limitations

This was a single center study with a relatively small sample size. Our study included only nasosinus surgeries and with respect to the endotracheal tube, the number of attempts, time taken for insertion and cuff pressure were not analyzed in this study.

Generalisability

Randomized controlled trials (RCTs) provide the highest level of evidence. In this study we utilised the anti-inflammatory property of fluticasone furoate on reducing POST, which is one of the most disturbing after effects post-endotracheal intubation. Even though our study showed lesser incidence and severity of POST as well as hoarseness of voice it was not statistically significant, which might be due to small sample size in each group. Thus, after proving with an adequate sample size, our intervention could be applicable and would be beneficial in reducing the incidence of POST in patients undergoing endotracheal intubation.

Conclusions

The frequency and severity of POST and hoarseness of voice in patients undergoing nasosinus surgery under general anesthesia with endotracheal intubation were not significantly reduced by fluticasone furoate-impregnated throat packs. It gave a higher satisfaction score after 24 hours even though it was statistically insignificant.

Data availability Underlying data

Due to the fact that open posting of data on a repository was not included in the study information sheet at the time the study was done, data access will be granted once users have consented to the data sharing agreement and provided written plans and justification for what is proposed with the data. Data access may be obtained by submitting a request to the corresponding author.

Extended data

Figshare: Protocol, https://doi.org/10.6084/m9.figshare.23850630.v4. ³⁹

This project contains the following extended data: -

CONSORT Checklist.doc

Proforma.docx

Informed consent.docx

Protocol.doc

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

References 1

Tanaka

Nakayama

Nishimori

: Lidocaine for preventing postoperative sore throat. Cochrane Database Syst. Rev. 2015;7. 10.1002/14651858.CD004081.pub3

Higgins

Chung

Mezei

: Postoperative sore throat after ambulatory surgery. Br. J. Anaesth. 2002 Apr 1;88(4):582–584. 10.1093/bja/88.4.582

Sharma

Bhardwaj

Sharma

: Dexamethasone to decrease post-anesthesia sore throat (POST) and hoarseness-which is the most effective route: intravenous, topical, or nebulization? A prospective randomized trial. Ain-Shams J. Anesthes. 2021 Dec;13(1):1–7. 10.1186/s42077-021-00144-8

El-Boghdadly

Bailey

Wiles

: Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706–717. 10.1111/anae.13438

Winkel

Knudsen

: Effect on the incidence of postoperative sore throat of 1 percent cinchocaine jelly for endotracheal intubation. Anesth. Analg. 1971 Jan 1;50(1):92–94. 5100250

10.1213/00000539-197101000-00018

Saeki

Morimoto

Yamashita

: Postoperative sore throat and intracuff pressure: comparison among endotracheal intubation, laryngeal mask airway and cuffed oropharyngeal airway. Masui. 1999 Dec 1;48(12):1328–1331. 10658413

Lee

Park

Jeong

: Combined intraoperative paracetamol and preoperative dexamethasone reduces postoperative sore throat: a prospective randomized study. J. Anesth. 2017 Dec;31:869–877. 28980140

10.1007/s00540-017-2411-6

Bao

Wang

: The size of endotracheal tube and sore throat after surgery: a systematic review and meta-analysis. PLoS One. 2013 Oct 4;8(10):e74467. 24124452

10.1371/journal.pone.0074467

PMC3790787

Chang

Kim

Han

: Effect of endotracheal tube cuff shape on postoperative sore throat after endotracheal intubation. Anesth. Analg. 2017 Oct 1;125(4):1240–1245. 28368938

10.1213/ANE.0000000000001933

Sato

Tanaka

Nishikawa

: Changes in intracuff pressure of endotracheal tubes permeable or resistant to nitrous oxide and incidence of postoperative sore throat. Masui. 2004 Jul 1;53(7):767–771. 15298243

Joe

Kim

Chae

: The effect of cuff pressure on postoperative sore throat after Cobra perilaryngeal airway. J. Anesth. 2012 Apr;26:225–229. 22127511

10.1007/s00540-011-1293-2

PMC3328671

Fennessy

Mannion

Kinsella

: The benefits of hypopharyngeal packing in nasal surgery: a pilot study. Ir. J. Med. Sci. 2011 Mar;180:181–183. 10.1007/s11845-010-0601-4

Karbasforushan

Hemmatpoor

Makhsosi

: The effect of pharyngeal packing during nasal surgery on the incidence of post-operative nausea, vomiting, and sore throat. Iran J. Otorhinolaryngol. 2014 Oct;26(77):219–223. 25320699

Zhang

Zhao

: Prophylactic administration of corticosteroids for preventing postoperative complications related to tracheal intubation: a systematic review and meta-analysis of 18 randomized controlled trials. Clin. Drug Investig. 2016 Apr;36:255–265. 10.1007/s40261-015-0369-4

Najafi

Imani

Makarem

: Postoperative sore throat after laryngoscopy with macintosh or glide scope video laryngoscope blade in normal airway patients. Anesthesiol. Pain Med. 2014 Feb;3(1). 10.5812/aapm.15136

Ansari

Bohluli

Mahaseni

: The effect of endotracheal tube cuff pressure control on postextubation throat pain in orthognathic surgeries: a randomized double-blind controlled clinical trial. Br. J. Oral Maxillofac. Surg. 2014 Feb 1;52(2):140–143. 24268872

10.1016/j.bjoms.2013.10.005

Sun

Guo

Sun

: Dexamethasone for preventing postoperative sore throat: a meta-analysis of randomized controlled trials. Ir. J. Med. Sci. 2014 Dec;183:593–600. 24357270

10.1007/s11845-013-1057-0

Canbay

Celebi

Sahin

: Ketamine gargle for attenuating postoperative sore throat. Br. J. Anaesth. 2008 Apr 1;100(4):490–493. 18310675

10.1093/bja/aen023

Kadar

: Assessment of the efficacy of dexamethasone, lignocaine or placebo in the prevention of post intubation sore throat. Int. J. Biomed. Res. 2015;6(07):493–503. 10.7439/ijbr.v6i7.2310

Chang

Min

Kim

: The effect of benzydamine hydrochloride prophylaxis on postoperative sore throat and hoarseness after tracheal intubation using a double-lumen endobronchial tube: a randomized controlled trial. Can. J. Anaesth. 2015 Oct;62:1097–1103. 26149601

10.1007/s12630-015-0432-x

Teymourian

Mohajerani

Farahbod

: Magnesium and ketamine gargle and postoperative sore throat. Anesth. Pain Med. 2015 Jun;5(3):e22367. 26161316

10.5812/aapm.5(3)2015.22367

PMC4493740

Wang

: Comparative efficacy of 6 topical pharmacological agents for preventive interventions of postoperative sore throat after tracheal intubation: A systematic review and network meta-analysis. Anesth. Analg. 2021 Jul;133(1):58–67. 33886521

10.1213/ANE.0000000000005521

PMC8183478

Thompson

Hayward

Heneghan

: Corticosteroids for sore throat. Cochrane Database Syst. Rev. 2010;1. 10.1002/14651858.CD008268

Smarius

Guillaume

Jonker

: The use of throat packs in pediatric cleft lip/palate surgery: a retrospective study. Clin. Oral Investig. 2018 Dec;22:3053–3059. 29473105

10.1007/s00784-018-2387-0

PMC6224011

Bajwa

: Prevention of aspiration of blood with a unique pharyngeal packing method. Anesth. Essays Res. 2012 Jul;6(2):251–252. 25885633

10.4103/0259-1162.108361

PMC4173445

Mencke

Echternach

Kleinschmidt

: Laryngeal morbidity and quality of tracheal intubation: a randomized controlled trial. The Journal of the American Society of Anesthesiologists. 2003 May 1;98(5):1049–1056. 10.1097/00000542-200305000-00005

Biro

Seifert

Pasch

: Complaints of sore throat after tracheal intubation: a prospective evaluation. Eur. J. Anaesthesiol. 2005 Apr;22(4):307–311. 10.1017/S0265021505000529

Lautenbacher

Peters

Heesen

: Age changes in pain perception: a systematic-review and meta-analysis of age effects on pain and tolerance thresholds. Neurosci. Biobehav. Rev. 2017 Apr 1;75:104–113. 28159611

10.1016/j.neubiorev.2017.01.039

Petrini

Matthiesen

Arendt-Nielsen

: The effect of age and gender on pressure pain thresholds and suprathreshold stimuli. Perception. 2015 May;44(5):587–596. 26422905

10.1068/p7847

Feine

Bushnell

Miron

: Sex differences in the perception of noxious heat stimuli. Pain. 1991 Mar 1;44(3):255–262. 10.1016/0304-3959(91)90094-E

Jaensson

Gupta

Nilsson

: Gender differences in sore throat and hoarseness following endotracheal tube or laryngeal mask airway: a prospective study. BMC Anesthesiol. 2014 Dec;14(1):1–8. 10.1186/1471-2253-14-56

Jayes

Haslam

Gratziou

: SmokeHaz: systematic reviews and meta-analyses of the effects of smoking on respiratory health. Chest. 2016 Jul 1;150(1):164–179. 27102185

10.1016/j.chest.2016.03.060

Thomson

: Asthma and smoking-induced airway disease without spirometric COPD. Eur. Respir. J. 2017 May 1;49(5):1602061. 28461294

10.1183/13993003.02061-2016

Lee

Sim

Kim

: Incidence and risk factors of postoperative sore throat after endotracheal intubation in Korean patients. J. Int. Med. Res. 2017 Apr;45(2):744–752. 28173712

10.1177/0300060516687227

PMC5536682

Patil

Sonavdekar

Mathur

: A Relative Study on Laryngeal Mask Airway Lubrication with 0.005% Beclomethasone Cream v/a 2% Lidocaine.

Sultan

Fahmy

Hassan

: Soaking oro-pharyngeal pack with triamcinolone acetonide lowers discomfort in functional endoscopic sinus surgeries. Rev. Chil. Anest. 2020;49:889–895. 10.25237/revchilanestv49n06-15

Park

Lee

: Application of triamcinolone acetonide paste to the endotracheal tube reduces postoperative sore throat: a randomized controlled trial. Can. J. Anesth. 2011 May 1;58(5):436–442. 21359615

10.1007/s12630-011-9478-6

Aqil

Khan

Mansoor

: Incidence and severity of postoperative sore throat: a randomized comparison of Glidescope with Macintosh laryngoscope. BMC Anesthesiol. 2017 Dec;17(1):1–8. 10.1186/s12871-017-0421-4

Kanakalakshmi

: Protocol.[Dataset]. figshare. 2023. 10.6084/m9.figshare.23850630.v4

10.5256/f1000research.153042.r237023

Reviewer response for version 1

Sarma

Riniki

1 Referee 1All India Institute of Medical Sciences, Delhi, New Delhi, India

Competing interests: No competing interests were disclosed.

9 2 2024

2024

This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

recommendation

approve

This randomized controlled trial takes into account an innovative drug to find the outcome of sore throat and hoarseness of voice postoperatively in patients undergoing endotracheal intubation. Fluticasone is a known treatment method used in rhinosinusitis due to its anti-inflammatory properties. Though not statistically significant, in view of the incidence of POST being lesser with fluticasone group, the findings from this study are encouraging.

Is the work clearly and accurately presented and does it cite the current literature?

Yes

If applicable, is the statistical analysis and its interpretation appropriate?

Yes

Are all the source data underlying the results available to ensure full reproducibility?

Yes

Is the study design appropriate and is the work technically sound?

Yes

Are the conclusions drawn adequately supported by the results?

Yes

Are sufficient details of methods and analysis provided to allow replication by others?

Yes

Reviewer Expertise:

AIrway, resuscitation, Pain management

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Kanakalakshmi

Sushma Thimmaiah

Anesthesiology, Kasturba Hospital Manipal, Manipal, Karnataka, India

Competing interests: No competing interests were disclosed.

24 3 2024

Riniki Sarma

Response

Many thanks for your comments madam.

Thank you for your motivating comments.

10.5256/f1000research.153042.r217314

Reviewer response for version 1

George

Mathew

1 Referee https://orcid.org/0000-0001-8865-2975 1Amrita Institute of Medical Sciences and Research Centre, Kochi, India

Competing interests: No competing interests were disclosed.

9 2 2024

2024

recommendation

approve-with-reservations

The study is well designed and executed. The background research is also commendable. If possible it would be better to continue patient enrolment to achieve the calculated sample size of 96 patients per group as it would possibly improve the power of the study and likely bring out a significant difference between the groups as there is a trend towards fluticasone decreasing the incidence of the primary outcome.

The paragraph on secondary outcome needs some correction as the number of patients with grade 2 soreness is not mentioned appropriately, or has been missed.

Altogether the paper is well designed and reasonably well written but is underpowered to reveal the true benefits if any for the treatment being studied.

Is the work clearly and accurately presented and does it cite the current literature?

Partly

If applicable, is the statistical analysis and its interpretation appropriate?

Yes

Are all the source data underlying the results available to ensure full reproducibility?

Yes

Is the study design appropriate and is the work technically sound?

Yes

Are the conclusions drawn adequately supported by the results?

Yes

Are sufficient details of methods and analysis provided to allow replication by others?

Yes

Reviewer Expertise:

Neuro anaesthesia, Paediatric Anaesthesia, Intraoperative evoked potential monitoring

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Kanakalakshmi

Sushma Thimmaiah

Anesthesiology, Kasturba Hospital Manipal, Manipal, Karnataka, India

Competing interests: None

24 3 2024

Mathew George

Comment

Response

Many thanks for your comments. We are continuing the patient enrollment as suggested so as to improve the power of our study and trying to find any significant differences between the groups.

Comment

The paragraph on secondary outcome needs some correction as the number of patients with grade 2 soreness is not mentioned appropriately, or has been missed.

Response

Many thanks for your comments. We have made the necessary changes and highlighted the same.

Comment

Altogether the paper is well designed and reasonably well written but is underpowered to reveal the true benefits if any for the treatment being studied.

Response

Many thanks for your comments. We agree with your suggestion and thus are continuing recruiting patients so as to improve the overall number and power of the study.

10.5256/f1000research.153042.r241363

Reviewer response for version 1

Pawar

Ajinkya

1 Referee https://orcid.org/0000-0003-3985-5674 1Department of Conservative Dentistry and Endodontics, Nair Hospital Dental College, Mumbai, Maharashtra, India

Competing interests: No competing interests were disclosed.

7 2 2024

2024

recommendation

approve-with-reservations

The introduction of the manuscript titled "Effect of fluticasone-impregnated throat packs on postoperative sore throat (POST) and hoarseness of voice: A randomized clinical trial" provides a comprehensive overview of the background, rationale, and objectives of the study. Overall, the introduction is well-structured and informative. However, here are some comments on potential flaws or areas for improvement:

The introduction mentions the incidence of POST ranging from 12.1% to 70% and hoarseness from 4–43%. However, it would be helpful to provide the sources of these statistics to lend credibility to the claims. This is important for readers to evaluate the reliability and generalizability of the reported incidence rates.

The statement that POST is the eighth worst possible post-anesthesia effect is intriguing, but the source or reference for this specific ranking is not provided.

While the introduction mentions that throat packs have advantages, it briefly touches on the drawbacks, with POST being a major concern. Expanding on the drawbacks and potential complications associated with throat packs could provide a more balanced view and help readers understand the context for investigating alternative interventions.

The introduction discusses various interventions to reduce the frequency of POST, such as compact tracheal tubes, video laryngoscopy, cuff pressure control, steroids, NSAIDs, and different gargles. It might be beneficial to briefly mention the effectiveness or limitations of these interventions.

The introduction mentions a thorough search of the literature showing no evidence of studies involving the use of throat packs soaked with steroid sprays. While this highlights the novelty of the study, it would be helpful to elaborate on why this gap exists and why it is essential to address it.

The introduction mentions that fluticasone furoate is typically available as a nasal spray with no reported adverse effects. While this information is relevant, it might be helpful to briefly explain why fluticasone furoate is being considered for impregnating throat packs, especially in comparison to other available steroids or anti-inflammatory agents.

The specific objectives of the study are outlined at the end of the introduction, but the wording could be refined for clarity. Consider rephrasing to clearly state each objective and its significance in the context of the study.

Discussion

The section provides a thorough analysis of the study results and offers valuable insights. However, there are a few areas that could be addressed for clarity and completeness:

While the discussion emphasizes the significance of reducing POST for postoperative patient comfort, satisfaction, and overall hospital stay, it would be beneficial to delve deeper into the specific impact of POST on patients' experiences. Providing anecdotes or examples could help readers better understand the practical implications of mitigating POST.

The discussion briefly mentions the use of steroids for their anti-inflammatory effect in preventing POST. It would be helpful to expand on the rationale behind choosing fluticasone furoate specifically, considering its anti-inflammatory properties and its potential advantages over other steroids. This could strengthen the justification for the study intervention.

The discussion compares the results of the current study with findings from previous research, particularly the study by Park SY et al (Ref1). However, it would be beneficial to discuss any differences in study design, patient populations, or interventions that may contribute to variations in results.

The discussion touches upon the small sample size as a potential reason for the lack of statistical significance in certain outcomes. It would be beneficial to discuss the implications of the study's limitations on the generalizability of the findings. Additionally, addressing the types of patients or surgeries to which the results may be more applicable could enhance the discussion.

Considering the study's findings and limitations, it would be helpful to suggest potential avenues for future research. This could include recommendations for larger multi-center trials, exploring different patient populations, or investigating variations in the intervention protocol.

Ensure consistency in reporting findings. For instance, the discussion mentions a lower incidence and severity of POST in the fluticasone group, but then notes that the results were not statistically significant. Clarify whether these observed differences are clinically meaningful even if not statistically significant.

Acknowledge the strengths of the study, such as the randomized controlled trial design and the use of a specific intervention that has not been extensively studied before. Recognizing these strengths reinforces the scientific rigor of the research.

Is the work clearly and accurately presented and does it cite the current literature?

Yes

If applicable, is the statistical analysis and its interpretation appropriate?

Yes

Are all the source data underlying the results available to ensure full reproducibility?

Yes

Is the study design appropriate and is the work technically sound?

Yes

Are the conclusions drawn adequately supported by the results?

Yes

Are sufficient details of methods and analysis provided to allow replication by others?

Yes

Reviewer Expertise:

Clinical Trial

References 1

: Application of triamcinolone acetonide paste to the endotracheal tube reduces postoperative sore throat: a randomized controlled trial. Can J Anaesth .2011;58(5) : 10.1007/s12630-011-9478-6 436-42

21359615

10.1007/s12630-011-9478-6

Kanakalakshmi

Sushma Thimmaiah

Anesthesiology, Kasturba Hospital Manipal, Manipal, Karnataka, India

Competing interests: No competing interests were disclosed.

10 5 2024

However, here are some comments on potential flaws or areas for improvement:

Comment

Response

Many thanks for your suggestion. We have changed the prevalence of POST and hoarseness of voice and have mentioned them in the revised manuscript.

Comment

The statement that POST is the eighth worst possible post-anesthesia effect is intriguing, but the source or reference for this specific ranking is not provided.

Response

Many thanks for your suggestion. We have changed the statement and have mentioned in the revised manuscript.

Comment

Response

Many thanks for your suggestion. We have added supporting study and have mentioned them in the revised manuscript.

Comment

Response

Many thanks for your suggestion. We have added supporting studies and have mentioned in the revised manuscript.

Comment

Response

Many thanks for your suggestion. We have added the supporting study and have mentioned in the revised manuscript.

Comment

The introduction mentions that fluticasone furoate is typically available as a nasal spray with no reported adverse effects. While this information is relevant, it might be helpful to briefly explain why fluticasone furoate is being considered for impregnating throat packs, especially compared to other available steroids or anti-inflammatory agents.

Response

Many thanks for your suggestion. We have added the supporting study and have mentioned it in the revised manuscript.

Comment

Response

Many thanks for your suggestion. We have made the necessary changes and have mentioned them in the revised manuscript.

Discussion

The section provides a thorough analysis of the study results and offers valuable insights.

However, there are a few areas that could be addressed for clarity and completeness:

Comment

Response

Many thanks for your suggestion. We have added the studies and have mentioned them in the revised manuscript.

Comment

Response

Many thanks for your suggestion. We have made the necessary changes and have mentioned them in the revised manuscript.

Comment

Response

Many thanks for your suggestion. We have made the necessary changes and have mentioned them in the revised manuscript.

Comment

The limitations section provides essential information about the constraints of the study, such as the single-center design and relatively small sample size. However, there is a mention of not analyzing certain aspects related to endotracheal tubes, such as the number of attempts, time for insertion, and cuff pressure. The discussion touches upon the small sample size as a potential reason for the lack of statistical significance in certain outcomes. It would be beneficial to discuss the implications of the study's limitations on the generalizability of the findings. Additionally, addressing the types of patients or surgeries to which the results may be more applicable could enhance the discussion.

Response

Many thanks for your suggestion. We have made the necessary changes and have mentioned them in the revised manuscript.

Comment

Considering the study's findings and limitations, it would be helpful to suggest potential avenues for future research. This could include recommendations for larger multi-centre trials, exploring different patient populations, or investigating variations in the intervention protocol.

Response

Many thanks for your suggestion. We have made the necessary changes and have mentioned them in the revised manuscript

Comment

Response

Many thanks for your suggestion. Although the observed differences were clinically meaningful they were not statistically significant as mentioned in our study.

Comment

Response

Many thanks for your suggestion. We have made the necessary changes and have mentioned them in the revised manuscript