Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?
Part of paid clinical trials in Temple, Texas.
- Sponsor
- Baylor Research Institute
- Study ID
- NCT06505148
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Pediatric Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 3 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Acetaminophen — DRUGadministered alternatively with other drug
- Ibuprofen — DRUGadministered alternatively with other drug
Study Details
To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock.
Key Dates
- Start date
- Aug 1, 2024
- Status verified
- Jul 2024
- Primary completion
- Aug 1, 2025
- Completion
- Aug 1, 2025
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Group AGroup A will prescribe study participants in group 1 acetaminophen and ibuprofen alternating treatment every three hours. The dosage will be weight-based.
- Active Comparator: Group BGroup B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based.
Primary Outcome Measure
Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale. [ Time Frame: 24, 48, and 72 hours after surgery ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Baylor Scott & White Health Temple Market | Temple | Texas | 76508 |
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