Effect of Steroids on Post-tonsillectomy Morbidities

Study Overview
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Brief Summary
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This study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy morbidities. Half of the patients who comply with the inclusion criteria were selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo.

Detailed Description
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The effect of preoperative systemic steroids on post-tonsillectomy morbidities such as pain, nausea, vomiting and delayed feeding was proven. However, this study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on the aforementioned morbidities and on decreasing the duration and costs of hospital stays. patients who were in the waiting list for tonsillectomy procedure were screened for medical history and those who comply with the inclusion criteria were randomly assigned into two equal groups of 50 patients each. One group was selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo. Questionnaires investigating postoperative pain, nausea, vomiting, and oral intake were answered by patients, parents or guardians where applicable.

Official Title
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Effect of Steroids on Post-tonsillectomy Morbidities

Conditions
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Postoperative Pain, Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: IV dexamethasone
* Drug: Oral prednisolone
* Drug: Paracetamol
* Drug: IV saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in the waiting list for tonsillectomy under general anesthesia who accepted to participate in the study. Exclusion Criteria: Patients who are allergic to steroids or those who have medical conditions which contraindicate the use of steroid i.e diabetes mellitus, gastritis, or hypertension and those who were on exogenous steroid supplements.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV dexamethasone and oral Prednisolone<br>Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). | Drug: IV dexamethasone<br>* 0.15 mg/kg<br>* Other names: Decadron;Drug: Oral prednisolone<br>* 0.25mg/kg/day for 7 days then tapering for next 7 days<br>* Other names: Predosone;Drug: Paracetamol<br>* acetaminophen 15 mg/kg/dose every 6 hours<br>* Other names: Adol;|
| Active Comparator: Placebo<br>Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). | Drug: Paracetamol<br>* acetaminophen 15 mg/kg/dose every 6 hours<br>* Other names: Adol;Drug: IV saline<br>* IV saline<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Severity of Post-operative Pain | 5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting) | The severest pain grade felt within a week | 
| Duration of Post-operative Pain | 4 selections (1 day, 2 days, 3 days, if more specify) | number of days at which pain was experienced within the the 1st sevn days post -surgery | 
| Occurence of Post-operative Nausea | Postoperative nausea occurence (yes, no) | 7 days | 
| Onset of Post-operative Nausea | Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day) | onset of 1st ocurence of nausea attack within the 1st week post-surgery | 
| Duration of Post-operative Nausea | Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify) | 7 days | 
| Occurence of Postoperative Vomiting | Postoperative vomiting occurrence (yes, no) | 7 days | 
| Total Number of Post-operative Vomiting Episodes | Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify) | total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of 1st Post-operative Oral Intake | feeding onset (1st day i. surgery day, 2nd day, 3rd day) | Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery | 
| Average Amount of Meal Per Day | adequacy of meals (inadequate, adequate) | 3 days | 
| Average Frequency of Meals Per Day | average frequency of meals (1 meal, 2 meals, if more specify) | average number of meals consumed per day for the 1st three days post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexamethasone, Prednisolone, Tonsillectomy Nausea, Pain, Postoperative, Postoperative Nausea and Vomiting, Randomized controlled trial, Post-tonsillectomy pain, delayed feeding