IBUPAP Study for Pain Management in Children

• Status: Completed
• Trial end date: 2020-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Antonios Likourezos
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• ages 3-17 years old presenting to the pediatric ED

• treating physician deems patient required ibuprofen Tylenol or both for pain relief

Exclusion Criteria:

• 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