IBUPAP Study for Pain Management in Children

Completed · Phase 2

Conditions studied: Pain Management

In brief

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.

Key facts

Study ID

NCT03088800

Run by

Antonios Likourezos

People needed

90

Starts

2018-04-30

Expected to finish

2020-07-30

Last updated by the study team

2021-03-25

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ages 3-17 years old presenting to the pediatric ED
• treating physician deems patient required ibuprofen Tylenol or both for pain relief

You may not qualify if…

• documented or suspected pregnancy, (2)
• parental refusal,
• allergies to NSAIDS or APAP
• inability to tolerate oral medications or contraindications to oral medication route
• received analgesics within 4 hours prior to ED presentation
• inability to use pain scales

Where it is running

• Maimonides Medical Center — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.