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Pain Control in Pediatric Surgery: Acetaminophen and Ibuprofen

This study is looking at the best way to manage pain for children (ages 3 to 18) after general surgery, such as for hernias or appendectomies. Researchers want to compare two approaches: giving acetaminophen and ibuprofen alternately every 3 hours, versus giving them together at the same time around the clock. The goal is to see which method provides better pain control. Success will be measured by how much pain children report using different pain scales (FLACC, VAS, NPRS) at 24, 48, and 72 hours after surgery. You may be able to join if your child is having general surgery and is not allergic to acetaminophen or ibuprofen. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 80 participants. It compares two different ways of giving pain medication.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Pain levels will be measured at 24, 48, and 72 hours after surgery.

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NCT06505148

Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?

Not Yet Recruiting
PHASE4Ages 3–18InterventionalTreatment
Baylor Research Institute
~80 participants
Updated 2024-07-22 on ClinicalTrials.gov
What's tested:AcetaminophenIbuprofen

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale.
Measured over 24, 48, and 72 hours after surgery
+2 more outcomes measured

Conditions

Pediatric Disorder

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Where it's being run

1 sites across 1 states
Texas1

Who to contact

Marlene T Porter, PhD
[email protected]
254-724-9069
Email the study team

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Eligibility criteria

Inclusion

Age group: 3 years to 18 years
General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)

Exclusion

Patients who are allergic to acetaminophen and/or ibuprofen
Patients being evaluated by SANE or evaluated for nonaccidental trauma
Patients admitted post-op

What this trial measures

  • Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale.24, 48, and 72 hours after surgery

    Pain will be assessed using an age-appropriate pain rating scale. The FLACC is an interval scale quantifying pain behavior with scores ranging from 0 no pain behaviors to 10 most possible pain behaviors. The five categories of behaviors assessed with the FLAC include facial expressions, leg movement, activity, crying, and consolability.

  • Pain Visual Analog Scale (VAS)24, 48, and 72 hours after surgery

    This tool portrays a 10cm ruler visual and the patient selects the marker indicating their pain intensity, 0 indicating no pain to 10 indicating the worst pain possible.

  • Numeric Pain Rating Scale (NPRS)24, 48, and 72 hours after surgery

    The NPRS is scored on an 11-point scale where the higher the number indicating severe more the pain.