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

NCT06505148 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 024-301
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Disorder

Keywords

non opioid; pain management; pediatric pain; pediatric pain management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Parent/ guardian adherence

  72 hours after surgery

Study Arms (2)

Group A

EXPERIMENTAL

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; Drug: Ibuprofen

Group B

ACTIVE COMPARATOR

Group B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based.

Drug: Acetaminophen; Drug: Ibuprofen

Interventions

Acetaminophen DRUG

administered alternatively with other drug

Group A; Group B

Ibuprofen DRUG

administered alternatively with other drug

Group A; Group B

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead
• Baylor Scott and White Health: collaborator

Study Sites (1)

Baylor Scott & White Health Temple Market

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One group will be prescribed the acetaminophen and ibuprofen alternating every 3 hours. And the other group will be prescribed acetaminophen and ibuprofen combine treatment.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)