Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acetaminophen, Ibuprofen.
- Who it may be relevant to
- Registry conditions: Pediatric Disorder. Basic parameters: 3 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
The purpose of the study is to compare the difference in pain control in the pediatric general surgery population of those who receive alternating acetaminophen and ibuprofen every 3 hours to those who receive acetaminophen and ibuprofen combined therapy around the clock. Additionally, to investigate the difference in parent adherence to pain treatment plans between the alternating group from the combined group.
Interventions
- Drug Acetaminophen
administered alternatively with other drug - Drug Ibuprofen
administered alternatively with other drug
Primary outcome measures
- Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale. [Time frame: 24, 48, and 72 hours after surgery]
- Pain Visual Analog Scale (VAS) [Time frame: 24, 48, and 72 hours after surgery]
- Numeric Pain Rating Scale (NPRS) [Time frame: 24, 48, and 72 hours after surgery]
Secondary outcome measures (1)
- Parent/ guardian adherence [Time frame: 72 hours after surgery]
Eligibility criteria
Inclusion criteria
- Age group: 3 years to 18 years
- General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)
Exclusion criteria
- Patients who are allergic to acetaminophen and/or ibuprofen
- Patients being evaluated by SANE or evaluated for nonaccidental trauma
- Patients admitted post-op
The study will take place at McLane Children's Hospital Temple Market. Patients who are pregnant.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Baylor Scott & White Health Temple Market — Temple
Identifiers
NCT: NCT06505148 · 024-301