Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity

Status Terminated

Clinical Trial Summary

The goal of this study is determine if an oral systemic course of steroids is a safe and effective option in lowering pain and complications following adenotonsillectomy in various pediatric age groups. A double blind, placebo-controlled randomized clinical trial of steroids (dexamethasone) versus placebo postoperatively will be performed. Investigators will determine if there is a difference in post-operative pain and complications between groups.

Clinical Trial Description

Purpose: To determine if post-operative dexamethasone is a safe and effective option in the reduction of post-operative pain and morbidity following adenotonsillectomy in various pediatric age groups. Methods: The subject population will be patients between the ages of 3 and 17 who will undergo adenotonsillectomy. The study will consist of two double-blinded arms - patients receiving a course of oral dexamethasone (doses on post-operative days 2, 4, and 6; 0.5 mg/kg; max dose: 20 mg) in addition to standard pain control regimen and patients receiving an oral placebo course in addition to standard pain control regimen. In the diary they will receive, patients or caregivers will record when specific pain medications were taken each day, a symptoms survey, and pain ratings measured by the Wong-Baker FACES Pain Rating Scale. Patients are able to return their diary at a post-operative appointment at CHP Main, through email by scanning the diary or taking pictures with their phone, or through mailing in the survey in a pre-stamped envelope. Demographic information such as age, race, gender, and household income will be extracted from the diary and the electronic medical record. Information such as surgical technique, concurrent operations, post-operative pain prescription (types, weight based dosage, and total days prescribed) will be extracted from the electronic medical record and recorded as well. Outcomes measured will include pain scale rating and rates of complications between the two groups. Significance: If it can be demonstrated that dexamethasone after adenotonsillectomy can reduce pain, complications, or need for opioid analgesics without appreciable side effects, a strong argument can be made for the addition of this inexpensive medication to routine post-operative adenotonsillectomy care. This would help with limiting the burden of clinical course of tonsillectomy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04879823
Study type	Interventional
Source	University of Pittsburgh
Contact
Status	Terminated
Phase	Phase 3
Start date	August 5, 2021
Completion date	July 11, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.