Keywords
Pediatric anesthesia, Caudal block, Dexmedetomidine, Bupivacaine, Infraumbilical surgeries, Pain relief
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Geetha Sindhuja B and Chaudhary N. Protocol for a prospective comparative randomized clinical study for the comparison of two different doses of dexmedetomidine with bupivacaine in pediatric caudal anesthesia for infraumbilical surgeries in a tertiary hospital in central India [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:118 (https://doi.org/10.12688/f1000research.144139.1)
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Study Protocol
Protocol for a prospective comparative randomized clinical study for the comparison of two different doses of dexmedetomidine with bupivacaine in pediatric caudal anesthesia for infraumbilical surgeries in a tertiary hospital in central India
[version 1; peer review: awaiting peer review]
PUBLISHED 19 Feb 2024
OPEN PEER REVIEW
REVIEWER STATUS
This article is included in the Datta Meghe Institute of Higher Education and Research collection.
Abstract
Corresponding author:
Boddeda Geetha Sindhuja
Competing interests:
No competing interests were disclosed.
Grant information:
The author(s) declared that no grants were involved in supporting this work.
Copyright:
© 2024 Geetha Sindhuja B and Chaudhary N.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Geetha Sindhuja B and Chaudhary N. Protocol for a prospective comparative randomized clinical study for the comparison of two different doses of dexmedetomidine with bupivacaine in pediatric caudal anesthesia for infraumbilical surgeries in a tertiary hospital in central India [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:118 (https://doi.org/10.12688/f1000research.144139.1)
First published: 19 Feb 2024, 13:118 (https://doi.org/10.12688/f1000research.144139.1)
Latest published: 19 Feb 2024, 13:118 (https://doi.org/10.12688/f1000research.144139.1)
Introduction
Pediatric anesthesia, a field dedicated to providing safe and effective anesthesia care to infants and children, presents unique challenges and opportunities.1 Among the various techniques employed in pediatric anesthesia, using caudal blocks has become a cornerstone for providing intraoperative and postoperative pain relief, particularly in infraumbilical surgical procedures. Ensuring adequate analgesia in pediatric patients is essential for their comfort and well-being and plays a pivotal role in their postoperative recovery.2
Dexmedetomidine, an α2-adrenergic agonist, has garnered attention as a potential adjuvant to local anesthetics in caudal blocks, with the capacity to enhance the quality and duration of pain relief.3 Dexmedetomidine as an adjunct in regional anesthesia techniques, including caudal blocks, has shown promise in adult populations and has been increasingly explored in pediatric anesthesia. This adjuvant’s sedative, analgesic, and sympatholytic properties make it a compelling option for optimizing the pain management of pediatric patients.4
However, the optimal dosage of dexmedetomidine in combination with bupivacaine for pediatric caudal anesthesia remains a subject of investigation. This study protocol outlines a comprehensive approach to address this question through a prospective comparative randomized clinical study conducted in a tertiary hospital in Central India. By comparing the outcomes between two groups of pediatric patients receiving different doses of dexmedetomidine, this research aims to evaluate the efficacy, safety, and cost-effectiveness of this adjuvant in the context of infraumbilical surgeries. The results of this study are expected to provide valuable insights that can guide clinical practice, enhance anesthesia protocols for pediatric patients, and improve pain management strategies in the unique setting of a tertiary hospital in Central India.
Aim
The primary aim of this prospective comparative randomized clinical study is to assess the efficacy of two different doses of dexmedetomidine in combination with bupivacaine for pediatric caudal anesthesia during infraumbilical surgeries in a tertiary hospital in Central India.
Primary objective
To compare the analgesic efficacy, as measured by the duration of postoperative pain relief, between two different doses of dexmedetomidine in combination with bupivacaine for pediatric caudal anesthesia during infraumbilical surgeries.
Secondary objectives
1. To assess the intraoperative hemodynamic stability in both study groups.
2. To evaluate the time to the first requirement of rescue analgesia in the two study groups.
3. To compare the incidence of adverse effects or complications related to caudal anesthesia between the two groups.
4. To assess the overall patient and parent satisfaction with the anesthesia technique in both study groups.
5. To analyze the cost-effectiveness of the two anesthesia regimens.
Methods
Study setting
This prospective comparative randomized clinical study will be conducted in the Department of Anaesthesiology at Jawaharlal Nehru Medical College (JNMC) and Acharya Vinoba Bhave Rural Hospital (AVBRH), a tertiary hospital in Central India. The study will encompass infraumbilical surgeries conducted in this hospital. This study protocol adheres to the SPIRIT checklist.13 The study proforma can be found as Extended data.12
Interventions
To facilitate transparency and reproducibility, the interventions for each study group, along with details on administration, criteria for discontinuation or modification, adherence strategies, and relevant concomitant care, are presented below.
Group A (n=30)
Patients in this group will undergo caudal block with 1 ml/kg of 0.25% bupivacaine. Simultaneously, a solution of 1 μg/kg dexmedetomidine will be constituted to 1 ml and administered via the caudal route. The administration of bupivacaine and dexmedetomidine will be carried out following established aseptic techniques, with emphasis on proper identification of the sacral hiatus and precise injection into the caudal epidural space.
Group B (n=30)
Patients in this group will receive a caudal block with 1 ml/kg of 0.25% bupivacaine. Additionally, a solution of 0.5 μg/kg dexmedetomidine will be constituted to 1 ml and administered via the caudal route, following the same standardized procedures outlined for Group A.
Criteria for discontinuing or modifying allocated interventions
Several scenarios may prompt the discontinuation or modification of allocated interventions. These include, but are not limited to, adverse events necessitating a change in drug dosage, participant requests, or variations in disease progression (improvement or worsening). Any modifications to the allocated interventions will be carefully documented, and the rationale for such changes will be recorded in the participant’s case report form.
Strategies to improve adherence to intervention protocols
To enhance adherence, comprehensive training sessions will be conducted for the healthcare providers involved in administering the interventions. Clear guidelines and protocols will be provided, emphasizing the importance of accurate drug dosages, aseptic techniques during administration, and adherence to the allocated intervention for each participant. Periodic reviews and audits will be conducted to monitor adherence, with a particular focus on documentation accuracy.
Monitoring adherence
Adherence to the intervention protocols will be monitored through regular assessments and reviews of the administered doses during team meetings. Additionally, any deviation from the protocol will be promptly documented and reported. Laboratory tests, including drug concentration assessments, may be employed to further validate adherence, ensuring the reliability and accuracy of the study’s findings.
Relevant concomitant care and interventions
Participants in both groups will receive standard perioperative care as per the hospital’s established protocols. Concomitant care and interventions that are permitted include routine monitoring of vital signs, administration of standard anesthesia during the surgical procedure, and any postoperative care deemed necessary for the patient’s well-being. Prohibited interventions will be clearly defined, and any deviations from the protocol will be documented and analyzed in the final study report.
Outcomes
Primary outcome
The primary outcome will be the duration of postoperative pain relief, measured as the time from the completion of the surgical procedure until the first requirement of rescue analgesia. This critical time interval will be expressed in minutes, providing a precise indicator of the efficacy of the interventions.
Secondary outcomes
1. Intraoperative hemodynamic stability:
2. Time to first requirement of rescue analgesia:
3. Incidence of adverse effects or complications:
• Measurement Variables: Presence or absence of adverse effects, such as hypotension, bradycardia, respiratory depression, or complications related to caudal anesthesia.
• Analysis Metric: Categorical data.
• Method of Aggregation: Recording and analyzing adverse events.
• Time Point: Throughout the perioperative period.
4. Patient and parent satisfaction:
5. Cost-effectiveness analysis:
• Measurement Variables: Economic implications of using different doses of dexmedetomidine in caudal anesthesia, including medication costs, monitoring expenses, and additional resources related to patient care.
• Analysis Metric: Cost-effectiveness ratios.
• Method of Aggregation: Comparative analysis of costs and outcomes.
• Time Point: Post-study period, during the economic analysis phase.
Explanation of clinical relevance
The selected outcomes were chosen to provide a comprehensive assessment of the interventions’ efficacy and safety. The primary outcome directly reflects the duration of postoperative pain relief, a critical factor in patient recovery. Secondary outcomes, such as hemodynamic stability, time to rescue analgesia, incidence of adverse effects, and patient satisfaction, offer a holistic view of both clinical and patient-centered aspects. The cost-effectiveness analysis further adds a practical dimension, considering the economic implications of implementing different doses of dexmedetomidine in caudal anesthesia. These outcomes collectively contribute to a thorough evaluation of the study’s objectives and potential clinical impact.
Sample size
The sample size will be determined utilizing the OpenEpi version 2.3.1 software, with a 95% confidence interval, a significance level (α) set at 0.05, and a desired statistical power (1-β) of 80%. Patients meeting the predefined inclusion criteria will be selected to participate in the study and subsequently randomized into one of two groups: Group A (n=30), where patients will receive a caudal injection of 1 ml/kg of 0.25% bupivacaine along with 1 μ/kg of dexmedetomidine, which is constituted to 1 ml; or Group B (n=30), in which patients will receive a caudal injection of 1 ml/kg of 0.25% bupivacaine along with 0.5 μ/kg of dexmedetomidine, also constituted to 1 ml.
A double-blind approach will be maintained throughout the study, ensuring that both the patients and their parents are unaware of the specific caudal medications administered. The preparation of medications will be handled by anesthesiologists who are not involved in the study except for drug preparation. The anesthesiologist responsible for administering anesthesia and monitoring the patient’s peri-operatively will remain unaware of the study drug to minimize potential biases and maintain the study’s scientific integrity.
Recruitment
1. Patient Identification: Patients scheduled for infraumbilical surgeries in the Department of Anaesthesiology at Jawaharlal Nehru Medical College (JNMC) and Acharya Vinoba Bhave Rural Hospital (AVBRH) will be identified as potential participants.
2. Screening: Patients meeting the inclusion and exclusion criteria will be screened for eligibility. This will involve assessing the age, ASA classification, and absence of allergies or contraindications to study drugs. Patients with developmental delays or intellectual disabilities will also be excluded.
3. Informed Consent: Once eligible patients are identified, the research team will approach their parents or legal guardians to obtain written and informed consent for participation in the study. The study objectives, procedures, potential benefits, and risks will be explained thoroughly.
4. Random Allocation: Eligible and consenting patients will be randomly allocated into either Group A or B using a randomization method to ensure an unbiased distribution of subjects.
5. Baseline Assessments: Before the scheduled surgery, all enrolled patients will undergo pre-operative assessments, including physical examinations, vital sign measurements, and relevant laboratory investigations.
6. Pre-Medication: Patients will be premedicated with glycopyrrolate, midazolam, and ketamine in the preoperative room, following which IV access will be established.
7. Operative Room Preparation: In the operating room, patients will receive appropriate IV fluids based on their weight and be placed in the left lateral position for the caudal block procedure.
8. Caudal Block Procedure: Caudal epidural anesthesia will be administered to patients in both groups, with the specific study drugs used according to the group assignment.
9. Anesthesia and Surgery: Patients will be induced with propofol and proceed according to the standard surgical protocol.
10. Monitoring: During the surgery, continuous monitoring of vital signs (heart rate, blood pressure, oxygen saturation) will be performed, recording any intraoperative hemodynamic fluctuations or adverse events.
11. Postoperative Care: Patients will be closely observed in the post-anesthesia care unit after surgery, and vital signs will be recorded. Postoperative monitoring will continue regularly to assess the primary and secondary outcomes.
12. Data Collection: Data related to the primary and secondary outcomes, including the duration of postoperative pain relief, time to the first requirement of rescue analgesia, adverse effects, patient and parent satisfaction, and cost-related information, will be systematically collected.
13. Follow-Up: Patients will follow the study protocol until the primary endpoint is reached (i.e., the time to the first requirement of rescue analgesia).
Allocation
The allocation of patients into two study groups, Group A and Group B, will be performed using a randomization method to ensure an unbiased distribution of subjects. Random allocation is a critical aspect of the study’s design, as it helps prevent selection bias and ensures that patients are assigned to their respective groups in a manner that the researchers do not influence. This randomization can be achieved through computer-generated random numbers, random drawing of sealed envelopes, or randomization software. To maintain its integrity, the random allocation will be carried out by a study coordinator or an individual not directly involved in patient care.
Blinding
A double-blind approach will be implemented to maintain the study’s scientific rigor and minimize potential biases. This means that the patients and the healthcare providers involved in administering anesthesia and monitoring the patients will need to be made aware of which specific caudal medications are being administered. The anesthesiologist responsible for drug preparation will be the only individual aware of the study group assignments, and they will not participate in the anesthesia administration or patient monitoring. Blinding helps prevent the influence of expectations or preferences and ensures that this knowledge does not influence the study’s outcomes. It enhances the reliability and validity of the research findings. Patient and parent blinding is particularly important to avoid placebo effects or biased reporting of pain relief and satisfaction outcomes.
Data collection process
The data collection process for this prospective comparative randomized clinical study will involve a systematic and structured approach to gathering information on various study parameters. The following steps will be taken:
1. Pre-Study Training: The research team, including data collectors and healthcare providers, will receive training on the study protocol and data collection procedures. This training will ensure that all team members are familiar with the study objectives and methods and can collect data consistently and accurately.
2. Data Collection Forms: Data collection forms will be designed and standardized for each data element, including demographic information, medical history, vital signs, and primary and secondary outcome measures. These forms will be used to record data for each study participant.
3. Baseline Data Collection: Before surgery, baseline data will be collected during the pre-operative assessment. This will include demographic information (age, sex), ASA classification, medical history, and relevant laboratory results.
4. Intraoperative Data Collection: During the surgical procedure, the research team will continuously monitor and record vital signs, including heart rate, blood pressure, and oxygen saturation. Any significant fluctuations or adverse events will be documented.
5. Caudal Anesthesia Details: Specific details related to the caudal anesthesia procedure, including the drugs used, dosages, and techniques, will be recorded for each patient.
6. Postoperative Monitoring: Patients will be closely monitored in the post-anesthesia care unit after surgery, and data on vital signs and any immediate postoperative complications will be recorded. Postoperative monitoring will continue at regular intervals to assess the primary and secondary outcomes, including the duration of postoperative pain relief, time to the first requirement of rescue analgesia, adverse effects, and patient and parent satisfaction.
7. Patient and Parent Surveys: Patients and their parents will be asked to provide feedback on their satisfaction with the anesthesia technique. This will involve using standardized satisfaction surveys to gather subjective information.
8. Cost Data: Cost data related to the use of different doses of dexmedetomidine in caudal anesthesia will be collected, including medication costs, monitoring costs, and any additional resources used for patient care. These data will be used for the cost-effectiveness analysis.
9. Data Quality Assurance: Quality control measures will be implemented throughout the data collection process to ensure data accuracy and reliability. This will involve regular data reviews, double-checking data entry, and addressing discrepancies or missing information.
10. Data Storage and Security: Collected data will be securely stored to maintain confidentiality and privacy. Access to data will be restricted to authorized personnel only.
11. Data Analysis: Once all data are collected, they will be analyzed using appropriate statistical methods to address the study’s objectives and test hypotheses.
12. Reporting and Dissemination: The study’s results will be reported in a scientific format and disseminated through publications and presentations as appropriate.
Data management
In this clinical study, effective data management is paramount to ensure the accuracy, security, and reliability of the collected information. The process begins with utilizing standardized data collection forms thoughtfully designed to encompass all pertinent data elements. The information will be transcribed into an electronic database once these forms have been meticulously filled out during the data collection phase. A double data entry system may be adopted to enhance data quality and minimize errors. Following data entry, rigorous validation checks will be conducted to detect and rectify inconsistencies, missing values, and outliers, thereby upholding the quality and integrity of the data. Furthermore, data security is a priority, with strict access controls to safeguard patient confidentiality and privacy. Routine data backups will be carried out to mitigate the risk of data loss, while periodic reviews and audits of the database will ensure data accuracy and reliability.
Statistical methods
The statistical analysis of the study data is pivotal to elucidating the study’s objectives and testing hypotheses. A multifaceted set of statistical methods will be harnessed to conduct the analysis. The initial step involves generating descriptive statistics to provide an overview of the study population and pertinent variables. These statistics may include means, standard deviations, medians, and percentages. Various statistical tests and techniques will be applied in the inferential analysis, contingent on the data type and research questions. For the primary outcome, the “Duration of Postoperative Pain Relief,” survival analysis techniques such as Kaplan-Meier survival curves will be employed, and group comparisons will be conducted using log-rank tests. Secondary outcomes, like the time to the first requirement of rescue analgesia, will be subject to similar analysis. Intraoperative and postoperative data, encompassing vital signs and adverse effects, may undergo scrutiny with appropriate statistical tests such as t-tests or chi-square tests. Patient and parent satisfaction data will be analyzed descriptively using means and percentages. Furthermore, a cost-effectiveness analysis will be conducted, which involves calculating the incremental cost-effectiveness ratio (ICER) to gauge the cost-effectiveness of the two anesthesia regimens. Regression models may be invoked to explore relationships between predictor variables and outcomes, while subgroup analyses could shed light on the impact of variables like age or ASA classification. Statistical significance will typically be delineated by a p-value below 0.05, and statistical software packages like SPSS version 23 will facilitate the data analysis. Throughout the analysis, strict adherence to ethical guidelines will be maintained to ensure patient privacy and data confidentiality.
Monitoring
Data Monitoring Committee (DMC)
A Data Monitoring Committee (DMC) will be established to oversee the conduct of the trial and safeguard the interests of participants. The composition of the DMC will include individuals with expertise in pediatric anesthesia, biostatistics, and clinical trial methodology. Members of the DMC will be independent of the study investigators and the sponsor, ensuring unbiased and impartial oversight.
Role and reporting structure
The DMC will be responsible for reviewing the accumulating trial data to ensure participant safety, data integrity, and adherence to the protocol. The committee’s primary roles include assessing interim analyses, evaluating safety data, and making recommendations regarding the continuation, modification, or termination of the trial based on emerging evidence.
The DMC will report directly to the Steering Committee, which is responsible for the overall conduct of the trial. Regular and timely reports from the DMC will be communicated to the Steering Committee to inform decision-making regarding trial progression.
The DMC charter, outlining its specific roles, responsibilities, and operating procedures, will be available on request from the trial sponsor. In the absence of a specific charter in the protocol, further details about the DMC can be obtained from the trial sponsor.
Interim analyses and stopping guidelines
Interim analyses are not planned for this study due to its relatively short duration and the low-risk nature of the interventions. However, if unexpected safety concerns arise, the DMC will have the authority to conduct unplanned interim analyses to assess the emerging data.
Stopping guidelines will be predefined in the DMC charter and will include criteria related to participant safety, efficacy, or futility. The DMC will have access to interim results, and decisions to terminate the trial will be made by the DMC in consultation with the Steering Committee.
Adverse event collection, assessment, and reporting
The trial will employ a robust system for collecting, assessing, reporting, and managing adverse events. Solicited adverse events, as outlined in the protocol, will be systematically recorded. Additionally, participants will be encouraged to report any spontaneously occurring adverse events throughout the trial.
All adverse events will be assessed for severity, causality, and expectedness. Serious adverse events will be promptly reported to the relevant ethics committees and regulatory authorities in accordance with local regulations. Periodic safety reports will be submitted to regulatory bodies as required.
Trial conduct auditing
A thorough auditing process will be conducted to ensure the integrity and compliance of trial conduct. The auditing procedures will be detailed in a separate auditing plan, which will outline the frequency and specific procedures for auditing.
The auditing process will be independent of investigators and the sponsor. External auditors with expertise in clinical trial conduct will conduct audits at predetermined intervals, and any deviations from the protocol will be documented and reported.
Ethical considerations
Ethical considerations and ancillary/post-trial care
Approval and informed consent
The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has granted approval to the study protocol (Reference number: DMIHER (DU)/IEC/2022/86, Date: 20-07-2022). Additionally, the trial is registered with the Clinical Trials Registry – India (CTRI/2023/05/057050). Prior to study initiation, written informed consent will be obtained from all participants or their legal guardians, ensuring they are fully informed about the study’s objectives, procedures, potential risks, and benefits.
Ancillary care
Participants will receive ancillary care beyond the scope of the trial as required. Any adverse events or complications arising from trial participation will be promptly addressed, and necessary medical interventions will be provided at no cost to the participants. Ancillary care will extend to managing conditions unrelated to the trial that may arise during the study period, ensuring the overall well-being of the participants.
Post-trial care
Post-trial care will be provided to participants, particularly for any ongoing effects or complications related to the trial interventions. Participants will have access to appropriate medical care and follow-up visits, ensuring continuity of care beyond the trial’s conclusion. This post-trial care is integral to fulfilling the ethical responsibility towards trial participants.
Compensation for harm
Provisions for compensation will be in place for participants who may suffer harm from trial participation. In the event of an adverse event directly attributable to the study interventions, compensation will cover medical expenses, additional treatments, and any other related costs. The compensation process will be transparent, fair, and in compliance with local regulations and ethical guidelines.
These ethical considerations, encompassing ancillary and post-trial care, as well as compensation for harm, are integral components of the study protocol. They underscore the commitment to safeguarding the well-being of trial participants and reflect the ethical standards upheld by the research team and the Institutional Ethics Committee.
Discussion
The implementation of regional anesthesia techniques in pediatric anesthesia has evolved significantly over the years, emphasizing the importance of tailoring interventions to children’s unique physiological and anatomical characteristics. In this prospective comparative randomized clinical study, we have focused on applying dexmedetomidine, an α2-adrenergic agonist, as an adjuvant in pediatric caudal anesthesia for infraumbilical surgeries. Dexmedetomidine’s sedative, analgesic, and sympatholytic properties make it a compelling candidate for optimizing pain management strategies in the pediatric population.
Our primary outcome, the “Duration of Postoperative Pain Relief,” is a pivotal measure of the efficacy of the two different doses of dexmedetomidine in combination with bupivacaine. Extending the duration of analgesia is a paramount goal in pediatric anesthesia, as it contributes not only to immediate postoperative comfort but also to overall recovery and patient satisfaction. Previous studies in both pediatric and adult populations have demonstrated that dexmedetomidine can prolong the duration of local anesthetic action, an effect likely attributed to its interaction with α2-adreceptor subtypes in the spinal cord.5,6
While we anticipate that dexmedetomidine will enhance the duration of postoperative pain relief, the ideal dose remains uncertain. Our study compares 1 μ/kg and 0.5 μ/kg doses to balance efficacy and safety. As previously reported, higher doses of dexmedetomidine may result in more pronounced sedation, potentially necessitating increased vigilance in the postoperative period.7 The selected doses for this study are grounded in the existing literature and aim to optimize analgesia while minimizing potential side effects.
The secondary outcomes in our study encompass a range of clinically relevant parameters. Intraoperative hemodynamic stability is paramount, particularly in pediatric patients, and will be carefully assessed. Previous studies have demonstrated that dexmedetomidine can provide hemodynamic stability and attenuate the stress response to surgery.8,9 Therefore, monitoring for any fluctuations or adverse events is crucial.
The time to the first requirement of rescue analgesia is a key secondary outcome, directly reflecting the quality of pain relief. Dexmedetomidine’s analgesic properties are well-documented,10 and we anticipate that the group receiving the higher dose may first experience a more extended time to rescue analgesia. This outcome is a marker of analgesic efficacy and a critical component of patient satisfaction.
Patient and parent satisfaction is an essential component of the study. The experience and perception of pain management can significantly impact the overall satisfaction of pediatric patients and their families.11 By collecting feedback through standardized surveys, we aim to gain insights into the practical implications of our findings.
Furthermore, a cost-effectiveness analysis will provide a broader perspective on the implications of using different doses of dexmedetomidine in pediatric caudal anesthesia. As healthcare resources are limited, understanding the economic implications of various interventions is increasingly important. Our analysis will encompass medication costs, monitoring costs, and any additional resources related to patient care, ultimately contributing to informed decision-making in resource allocation.
This study protocol is set within pediatric anesthesia research, which continuously strives to refine techniques and improve outcomes for the youngest surgical patients. Although numerous studies have explored dexmedetomidine’s role in anesthesia and analgesia, its optimal use in pediatric caudal anesthesia remains an area of active investigation. Our study aims to add to the body of knowledge with implications for clinical practice.
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Geetha Sindhuja B and Chaudhary N. Protocol for a prospective comparative randomized clinical study for the comparison of two different doses of dexmedetomidine with bupivacaine in pediatric caudal anesthesia for infraumbilical surgeries in a tertiary hospital in central India [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:118 (https://doi.org/10.12688/f1000research.144139.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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