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

Phase 4

Not yet recruiting

• Conditions: Pediatric Disorder
• Interventions: Drug: Acetaminophen; Drug: Ibuprofen

• Registration Number: NCT06505148
• Lead Sponsor: Baylor Research Institute

Brief Summary

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-17
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22
• Study Start: 2024-08-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Acetaminophen	Group A will prescribe study participants in group 1 acetaminophen and ibuprofen alternating treatment every three hours. The dosage will be weight-based.
Group A	Ibuprofen	Group A will prescribe study participants in group 1 acetaminophen and ibuprofen alternating treatment every three hours. The dosage will be weight-based.
Group B	Acetaminophen	Group B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based.
Group B	Ibuprofen	Group B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Parent/ guardian adherence	72 hours after surgery	Adherence will be assessed by asking the parent/guardian regarding their ability to follow pain regimen and the ease to follow the instructions.

Trial Locations

Locations (1)

Baylor Scott & White Health Temple Market; 🇺🇸 Temple, Texas, United States