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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Disorder
• Intervention / Treatment: Drug: Acetaminophen; Drug: Ibuprofen

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Health Temple Market
      • Contact: Marlene T Porter, PhD; Phone Number: 254-724-9069; Email: marlene.porter@bswhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Acetaminophen; administered alternatively with other drug; Drug: Ibuprofen; administered alternatively with other drug
Active Comparator: Group B; Group B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based.	Drug: Acetaminophen; administered alternatively with other drug; Drug: Ibuprofen; administered alternatively with other drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale.	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.	24, 48, and 72 hours after surgery
Pain Visual Analog Scale (VAS)	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.	24, 48, and 72 hours after surgery
Numeric Pain Rating Scale (NPRS)	The NPRS is scored on an 11-point scale where the higher the number indicating severe more the pain.	24, 48, and 72 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: Baylor Scott and White Health

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: pain management; pediatric pain; non opioid; pediatric pain management
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 024-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data-sharing considerations will be addressed upon receipt of a formal request. Upon receipt of a formal request, data sharing will proceed once a data-sharing agreement has been established. The rationale for the data sharing plan is that data obtained for the study is considered proprietary to BSWH.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No