Official Title
Effect of Steroids on Post-tonsillectomy Morbidities
Phase
Phase 2Lead Sponsor
King Fahd General HospitalStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Postoperative Pain Postoperative Nausea and VomitingIntervention/Treatment
urea prednisone acetaminophen sodium chloride ...Study Participants
100This 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.
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.
0.15 mg/kg
0.25mg/kg/day for 7 days then tapering for next 7 days
acetaminophen 15 mg/kg/dose every 6 hours
IV saline
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 (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
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.
| Event Type | Organ System | Event Term | IV Dexamethasone and Oral Prednisolone | Placebo |
|---|
5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting)
4 selections (1 day, 2 days, 3 days, if more specify)
Postoperative nausea occurence (yes, no)
Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)
Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)
Postoperative vomiting occurrence (yes, no)
Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)
feeding onset (1st day i. surgery day, 2nd day, 3rd day)
adequacy of meals (inadequate, adequate)
average frequency of meals (1 meal, 2 meals, if more specify)
