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drugset / Trial / NCT03088800

IBUPAP Study for Pain Management in Children

NCT03088800 ↗

Phase 2 Completed 90 enrolled Antonios Likourezos
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2018-04-30
Primary completion
2019-10-31
Completion
2020-07-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 15 mg/kg Oral
Comparator Ibuprofen Small molecule 10 mg/kg Oral

Indications

No indication recorded.