CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 741 enrolled
Drug / intervention
Ibuprofen +1 moredrug
Likely dose
Ibuprofen 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01605903
NCT01605903Phase 2Completed

Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy

Massachusetts Eye and Ear Infirmary·interventional·Posted May 25, 2012·Updated Apr 24, 2018

In Brief

A Phase 2 clinical trial evaluating Ibuprofen and Acetaminophen for Tonsillectomy and Adenoidectomy. Completed, enrolled 741 participants across 5 sites.

Detailed Summary

Tonsillectomy (the surgical removal of the tonsils) is a commonly performed surgery in children. One risk of tonsillectomy is postoperative bleeding, and this can be more dangerous in children because their blood volume is lower than adults. Ibuprofen, a nonsteroidal anti-inflammatory medication (NSAID), is an effective pain medication. Recent guidelines, published by the American Academy of Otolaryngology, advocated use of ibuprofen after tonsillectomy. However, NSAIDs are associated with altered platelet function and a theoretical increased risk of bleeding after surgery. The investigators would like to explore the effect that ibuprofen has on postoperative bleeding, as well as validate previous studies demonstrating it is an effective pain medication after tonsillectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2012
Enrollment StartMay 3, 2012
Primary CompletionFeb 15, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.1 years ago

Interventions

Ibuprofendrug

Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.

Acetaminophendrug

During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.