NCT02401529

Effect of Steroids on Post-tonsillectomy Morbidities

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: King Fahd General Hospital · Other Government
• Sex: All
• Age: 5 Years – 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postoperative Pain
• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	IV dexamethasone	0.15 mg/kg
DRUG	Oral prednisolone	0.25mg/kg/day for 7 days then tapering for next 7 days
DRUG	Paracetamol	acetaminophen 15 mg/kg/dose every 6 hours
DRUG	IV saline	IV saline

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2015-03-30
• Last updated: 2015-07-15
• Results posted: 2015-07-15