Keywords
Tonsillectomy, Pharmacological management, post-tonsillectomy pain, Muhimbili national hospital, Tanzania
Tonsillectomy is among the standard procedures performed on the head and neck. Acute pain following tonsillectomy impairs recovery and contributes to physical discomfort. Adequate pharmacological management of post-operative pain increases the satisfaction and well-being of a patient. The aim of this study was to determine the pharmacological management of acute pain post-tonsillectomy in the otorhinolaryngology department at Muhimbili National Hospital (MNH)
A hospital-based prospective cohort study was carried out among 72 patients. A structured questionnaire was used to collect data from selected patients who underwent cold tonsillectomy. Postoperative pain assessment was conducted at six, 12, and 18 hours from initiation of pharmacological management following tonsillectomy. An interviewer-administered numerical rating scale was used for assessing postoperative pain scores.
A total of 72 patients were enrolled, of which most were female (73.6%). The majority of patients were in the age group of 8–15 years (50%). Paracetamol was the commonest analgesia prescribed (37.5%) post-tonsillectomy. The majority of patients experienced moderate pain at six- and 12-hours following tonsillectomy, 55.6% and 65.3%, respectively, whereas 88.9% of patients had mild pain at 18 hours after initial analgesic administration. Pain relief was attained by all patients aged 16–23 years (96.6%), all being female patients, and these differences were statistically insignificant. Paracetamol achieved pain reduction from moderate pain (59.3%) and severe pain (37.0%) at six hours to mild pain at 18 hours (88.9%).
Paracetamol was the commonly prescribed analgesic following tonsillectomy with majority of patients attaining moderate pain; however, there was no significant difference between the use of combined drugs and single drug use. This could be influenced by the sample size of the studied population and individual variations in pain perception.
Tonsillectomy, Pharmacological management, post-tonsillectomy pain, Muhimbili national hospital, Tanzania
Tonsillectomy is defined as a surgical procedure for completely removing the palatine tonsil, including its capsule. In-ear, nose, and throat surgeries, tonsillectomy is the most common procedure carried out.1
Post operative pain is a relevant occurrence following tonsillectomy and mismanagement of pain control has been reported in recent studies with no international standard pain therapy regime following tonsillectomy.2,3 The occurrence of pain is influenced by various factors such as duration of procedure, type of anaesthetic used intraoperatively, timing and type of post operative analgesia.4,5 In this study the timing and type of postoperative analgesia is of interest.
The numerical rating scale and visual analogue score are the most frequently used pain assessment tools offering reliable results and have been validated to be used in children from eight years and above.6,7
Various pharmacological modalities have been employed in managing pain following tonsillectomy, such include drugs like opioids and non-opioids analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), local anesthetics, paracetamol, ketamine and adjuvants. Recent studies emphasize on multimodal approach with the use of different drugs and techniques to achieve better therapeutic benefits with less side effects.8,9
Inadequacy of knowledge on pharmacological management post tonsillectomy particularly in developing countries lags behind efforts to reduce the burden of acute pain following tonsillectomy. The aim of this study is to determine postoperative pain management outcomes in patients who underwent tonsillectomy and encountered challenges in our setting; therefore, we may get a better insight and understanding on how to improve postoperative pain management in order to avoid complications.
The ethical clearance for conducting this study was sought from Directorate of Research and Publications of the Muhimbili University of Health and Allied Sciences with ethical approval number of MUHAS-REC-03-2022-1022 issued on 17/03/2022; and the approval to conduct the study at the Otorhinolaryngology department was provided by the Directorate of Clinical Services of the Muhimbili National Hospital (MNH). Written informed consent was requested from patients aged 18 years and above, and for those less than 18 years old assent was given, and their parents or guardians signed consent forms. All information collected was kept confidential.
This was a prospective descriptive cohort study conducted in the Otorhinolaryngology department at MNH, which is the national referral hospital in Tanzania. The study involved all patients aged eight years and above who underwent tonsillectomy under general anesthesia during a period of three months, from March to June 2022. A total of 72 patients were selected through a simple random sampling method. Inclusion criteria were those who consented to participate, mentally stable, with no communication barrier, who underwent only tonsillectomy as a surgical procedure.
A pretested, structured questionnaire was used to collect data from selected patients who met the inclusion criteria after seeking their written informed consent and assent.10 Following tonsillectomy, which was performed on all patients who participated in this study, data concerning the type of tonsillectomy, dose, frequency and route of analgesics given post operatively was obtained from the patient’s files. Patients were then asked to score their pain using the Numerical Rating Scale from 0 to 10. Assessment of pain score was done every six hours for a period of 18 hours, and the initiation of pharmacological management was the mark of the start of follow-up. Pain relief was defined as zero scores on the numerical rating scale (pain assessment tool). The follow-up ended whenever patients attained pain relief (zero scores on the numerical pain rating scale) or reached the end of follow-up (18 hours) with pain (censored).
Assistant investigators involved in this research, especially in data collection, were trained on how to fill out the questionnaires correctly to obtain accurate data.
The developed data tools were evaluated and standardized by conducting a pilot study where the data tools were assessed and evaluated by collecting opinions from participants and was reviewed by ENT specialists for opinions. Moreover, 10% of the data collection forms were randomly picked and tracked throughout the procedures to ensure correct data collection, entrance, and processing. The questionnaires were adjusted according to the analysis of results observed in the pilot study.
At the end of data collection, data were entered into SPSS software version 23 for analysis. Descriptive statistics were used to describe the socio-demographic and clinical characteristics of the study participants. This included frequencies for categorical variables and median (range) for numerical variables. The frequency distribution table was used to show the proportion of analgesic agents used in pain management. The cumulative incidence of pain intensity relief within 18 hours after initiation of pharmacological management post-tonsillectomy was calculated and reported in graphs and tables. A Chi-square test was used to assess pain score distribution according to pharmacological management following tonsillectomy. A p-value of less than 0.05 was considered statistically significant.
This study involved 72 patients who underwent tonsillectomy. The majority of patients were in the age group of 8–15 years, 50% (n = 36), with the median age of 16. Female patients contributed 73.6% (n = 53), with a female to male ratio of 2.8:1 (Table 1).
Variable | Frequency (n) | Percentage (%) |
---|---|---|
Age group (years) | ||
8–15 | 36 | 50 |
16–23 | 7 | 9.7 |
≥24 | 29 | 40.3 |
Median age in years (IQR) | 16 (10–29) | |
Sex | ||
Male | 19 | 26.4 |
Female | 53 | 73.6 |
Most patients were prescribed paracetamol (37.5%) post-tonsillectomy. The least prescribed drug was a combination of tramadol + paracetamol and ibuprofen + paracetamol + diclofenac by 1.39% for each (Table 2).
At six hours of pain assessment following initial analgesics administration the majority of patients (55.6%) experienced moderate pain, followed by severe pain (43.1%) and none had no pain. At 12 hours, most patients still had moderate pain 65.3% followed by mild pain 30.6% and few experienced no pain (0.6%). Finally, at 18 hours, there was a significant reduction in pain intensity as the majority experienced mild pain (88.9%), and none had severe pain.
Pain relief was attained by all patients aged 16–23 years and least by those aged ≥24 years (96.6%). However, of those who attained pain relief all were females, although these differences between age groups and sex were not statistically significant (Table 3).
At six hours, after the use of paracetamol, the majority of patients had moderate pain (59.3%) and severe pain (37%), while at 12 hours the majority still had moderate pain (66.7%) and none had severe pain. At 18 hours (88.9%) of patients had mild pain with few (3.7%) having no pain.
After the use of ibuprofen + paracetamol at six hours, the majority of patients had severe pain (53.8%) and moderate pain (46.2%), while at 12 hours, 73.1% had moderate pain and a few (11.5%) had severe pain, and at 18 hours the majority (84.6%) attained mild pain.
The majority of patients who used ibuprofen at six hours (58.3%) had moderate pain followed by severe pain (41.7%), while at 12 hours, an equal number of patients (50%) had mild and moderate pain. All patients achieved mild pain at 18 hours.
Patients who used ibuprofen + diclofenac at six hours (66.7%) had moderate pain, and all of them (100%) attained mild pain at 12 and 18 hours. Also, patients who used paracetamol + diclofenac achieved moderate pain (100%) at six and 12 hours and mild pain (100%) at 18 hours (Table 4).
Since tonsillectomy is one of the most commonly performed procedures, postoperative pain assessment is essential in the surgical patient care plan. Adequate post-operation pain management is important to prevent associated morbidity in patients, such as inadequate intake of oral liquids, recovery speed, and day to day activities.11
Paracetamol was the commonest analgesia prescribed (37.5%), followed by a combination of ibuprofen and paracetamol (36.11%), the similarity is seen with a study done by Mogane et al. where 90% of children were prescribed paracetamol12 and Warnock et al. where 60% of patients’ post-tonsillectomy were prescribed acetaminophen.13 Prescriptions were based on the surgeon’s preference in contrast to Fletcher et al. in a survey of post-operative pain where there was a room for patient-controlled analgesia with a predominance of paracetamol and subcutaneous morphine, 95.2% and 95.8% respectively.14 This is seen to be different from Tanzanian studies, where pethidine injection predominated by 50%, followed by tramadol.15,16 The difference could be explained by the differences in the nature of surgeries where various surgeries such as abdominal, head, neck, chest surgeries, surgeon preference, availability of analgesics in the hospital and the fact that no study has been done to assess post-operative analgesia following tonsillectomy alone.
Moderate pain was experienced at six hours and 12 hours following tonsillectomy, with 55.6% and 65.3%, respectively. This was followed by significant pain reduction where 88.9% of patients had mild pain at 18 hours after initial analgesic administration. Similarly, a study by Sommer et al. showed moderate pain was experienced on day 0, but in contrast, the pain persisted until day four of follow up17; this could be explained by the fact that pain after adult tonsillectomy stays high until day seven when it begins to decline. The similarity is also seen with Warnock et al., where moderate pain was scored on the first postoperative day with decreased pain intensity on day 7 of follow up as well as Hui et al. where moderate pain was scored on day one, and none had pain on day 14 of follow up.13,18
The differences in attaining pain relief exist among age groups and sex distribution in this study, although these differences were not statistically significant (p >0.05). An observation in this study showed that those aged above 24 years had less pain relief than those aged below, including children and young adults, by 96.6% versus 97–100%, although this difference is small, these findings appear to be similar to other previous studies where the pain was perceived more in adults than children.19,20 This is probably due to tissue fibrosis from recurrent tonsillitis and the associated complications such as dehydration and prolonged healing time that occurs more in adults than children.21 However, all females attained pain relief compared to males (89.5%); which contradicts a study done in Korea by Kim et al., where males had less pain than females.20 These findings were not statistically significant.
Pain score distribution was seen to be different with using different analgesics in this study, but these differences were not statistically significant (p >0.05). Pain reduction with combination drugs was seen to be more effective than single drug use; a similarity is seen in a study done in Tanzania.16,22 This is because of the advantageous combined synergistic effect on pain reduction.
The combined effect of paracetamol and ibuprofen was seen with pain reduction from moderate pain (46.2%) and severe pain (53.8%) at six hours to mild pain at 18 hours (84.6%). A similarity is seen with other studies including a study done by Liu et al. where the pain was unresolved in only 9.6% of patients.19 The use of NSAIDs, particularly ibuprofen, resulted in pain reduction; as observed in this study, pain relief was severe (41.7%) and moderate pain (58.3%) at six hours to mild pain (100%) at 18 hours. The similarity is seen with a study by Jensen et al., where ibuprofen was shown to be effective in pain reduction.22 This observation is due to its anti-inflammatory effect and its longer duration of action (6–8 hours) in contrast to paracetamol (4–6 hours), although they have the same therapeutic range at the correct dosage, and it is safety in terms of fewer side effects. This is in contrast to a study by Jotic et al. where satisfaction in pain management was equal with the use of ibuprofen and paracetamol.10
Pain assessment among patients who were given paracetamol showed adequacy in pain control. Relief of pain at 18 hours was no pain (3.7%) and mild pain (88.9%) compared to 59.3% of patients who had moderate pain and 37% who had severe pain at six hours. In this study, paracetamol was seen to work well in pain reduction. In contrast with other studies, paracetamol was observed to provide inadequate pain control on its own, especially in the early postoperative period, because of its shorter half-life of 1.5–2.5 hours. Dose control in other studies was important as it was associated with acute hepatic necrosis by depletion of glutathione and its reaction to vital cellular constituents.23 Therefore, it is seen to work best when combined with codeine24 or with ibuprofen.22
Our observation also showed that a combination of paracetamol or ibuprofen with diclofenac (NSAID) and/or tramadol (weak opioid) resulted in pain reduction from moderate pain (100%) with paracetamol and diclofenac to mild pain, and from moderate (66.7%) and severe (33.3%) pain with ibuprofen and diclofenac to mild pain (100%).This observation concurs with other studies where the use of tramadol was shown to have a better analgesic effect even when used on its own and has a lesser emetic effect than other opioids.25 However, individual variability within the cytochrome p450 system influences its variability, and its use in pediatric patients is limited by studies.26
There is evidence that, to date, there is no consensus on the appropriate analgesic, either single or in combination, to use following adult and pediatric tonsillectomy, given the bimodal pain pattern following tonsillectomy and its individual variation.27
The findings in this study showed that the most commonly prescribed analgesic was paracetamol followed by a combination of paracetamol and ibuprofen.
The majority of patients who attained pain relief according to pain intensity score within 18 hours following tonsillectomy were those who were aged between 16–23 years with female predominance, these differences were not statistically significant.
The use of combined drugs such as ibuprofen + diclofenac, paracetamol + diclofenac and ibuprofen + paracetamol showed better pain control than single drug use, although these differences were not statistically significant. This could be influenced by the sample size of the studied population and individual variations in pain perception.
Post tonsillectomy treatment protocols should emphasize the administration and use of combined analgesics as they have been shown to have a synergic effect. There is a need for future studies with larger sample sizes and standardization of intraoperative anaesthetic, choice, and dose of post operative analgesic in assessment of pain intensity following tonsillectomy.
i. Since it was a hospital-based study, the sample size may not represent all patients undergoing tonsillectomy in Tanzania.
ii. There is a lack of agreement regarding at what age numerical or ordinal pain assessment tools may be used in children and when behavioral tools are more appropriate.
iii. Lack of choice of analgesia and dosage standardization during the inward administration following tonsillectomy, as well as intraoperative standardization of the type of analgesia/steroid administration.
Written informed consent for publication of the patients’ details was obtained from the patients and parents or guardians of the patients.
Figshare: Underlying data and study questionnaires for ‘Pharmacological management of acute pain post-tonsillectomy in the otorhinolaryngology department at Muhimbili National Hospital’, https://doi.org/10.6084/m9.figshare.23790852. 10
Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).
We extend our gratitude to the study participants for their participation in this study, my fellow colleagues and the entire staff of Otorhinolaryngology for their valuable support during the study.
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