Effect of Steroids on Post-tonsillectomy Morbidities

Phase 2

Completed

Interventions: Drug: Paracetamol
Drug: IV dexamethasone
Drug: Oral prednisolone
Drug: IV saline

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
IV dexamethasone and oral Prednisolone	Oral prednisolone	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).
Placebo	Paracetamol	Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Placebo	IV saline	Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone and oral Prednisolone	IV dexamethasone	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).
IV dexamethasone and oral Prednisolone	Paracetamol	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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