CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 50 enrolled
Drug / intervention
Alternating Acetaminophen and Ibuprofen +1 moredrug
Likely dose
Not stated in 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/NCT04551196
NCT04551196Phase 3Completed

Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients

Washington University School of Medicine·interventional·Posted Sep 16, 2020·Updated Jul 11, 2024

In Brief

A Phase 3 clinical trial evaluating Alternating Acetaminophen and Ibuprofen and Combined Acetaminophen and Ibuprofen for Pain, Postoperative and 2 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.

Study Details

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

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedSep 16, 2020
Enrollment StartSep 28, 2020
Primary CompletionNov 10, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.8 years ago

Interventions

Alternating Acetaminophen and Ibuprofendrug

Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.

Combined Acetaminophen and Ibuprofendrug

Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.