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 — DRUG
    administered alternatively with other drug
  • Ibuprofen — DRUG
    administered 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 A
    Group 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 B
    Group 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)

FacilityCityStateZIPSite coordinators
Baylor Scott & White Health Temple MarketTempleTexas76508
Marlene T Porter, PhD
254-724-9069

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