Phase 2
Completed N=90
IBUPAP Study for Pain Management in Children
Pain Management
Source: ClinicalTrials.gov NCT03088800 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Pain Score at 60 Minutes — 2.72; 3.10; 2.77 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score at 60 Minutes |
2.72; 3.10; 2.77 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03088800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.