CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
Ibuprofen +1 moredrug
Likely dose
Ibuprofen 10 mg/kgfrom 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/NCT03088800
NCT03088800Phase 2Completed

IBUPAP - Combination of Oral Ibuprofen and Acetaminophen (APAP) is Superior to Either Analgesic Alone for Pediatric Emergency Department (ED) Patients With Acute Pain

Antonios Likourezos·interventional·Posted Mar 23, 2017·Updated Mar 25, 2021

In Brief

A Phase 2 clinical trial evaluating Ibuprofen and APAP for Pain Management. Completed, enrolled 90 participants across 1 site.

Detailed Summary

Current literature supports ibuprofen and APAP are the most commonly used analgesics in the pediatric ED for acute traumatic/non-traumatic pain. However, the analgesic benefits of combination ibuprofen and APAP in this specific setting does not exist, but instead only as it applies to pediatric patients with postoperative pain. Thus, we have designed a double-blind, randomized, controlled clinical trial to evaluate analgesic efficacy, safety and feasibility of combination therapy to potentially broaden its clinical application in the pediatric ED. The investigators' hypothesize that combination oral ibuprofen and APAP therapy is superior to either drug alone and is an excellent analgesic modality for controlling acute traumatic/non-traumatic pain in the pediatric ED.

Study Details

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

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 23, 2017
Enrollment StartApr 30, 2018
Primary CompletionOct 31, 2019
Study CompletionJul 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.3 years ago

Interventions

Ibuprofendrug

Oral Ibuprofen at 10 mg/kg dose

APAPdrug

Oral APAP at 15mg/kg dose