Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries

Not Applicable

Withdrawn

• Conditions: Pain, Acute; Pediatric ALL; Forearm Injuries
• Interventions: Drug: Oxycodone; Drug: Ibuprofen

• Registration Number: NCT04523623
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Children presenting to the Emergency Room with the chief complaint of forearm injury and/or pain will be randomized to receive oral Oxycodone or Ibuprofen to control pain.

Detailed Description

A randomized, blinded cohort study. Consented patients will be randomized to receive either ibuprofen or oxycodone after initial RN patient assessment in Emergency Department Triage determines a need for radiographs to evaluate for possible forearm fracture. Pain assessment scores will be determined at Triage and at 30-minute intervals throughout the patient's course until the patient is discharged home or additional analgesic medication is administered.

Study Timeline

• Study Start: 2020-07-28
• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-21
• Primary Completion: 2021-06-21
• Study Completion: 2021-06-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. 6 to 17 year old children presenting for care in the St. Louis Children's Hospital Emergency Department
2. Suspected acute (within 24 hours) isolated forearm fracture at the time of initial Triage assessment
3. American Society of Anesthesiologist physical status (ASA-PS) classification of I or II
4. Child with parent or legal guardian.

Exclusion Criteria

1. Multiple injuries
2. Known adverse reaction to either ibuprofen or oxycodone pts with abnormal bones or metabolic conditions that affect bones
3. Administration of any opioid within 2 hours prior to presentation
4. Non-English speaking
5. Foster care, police custody, presenting without legal guardian

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone Group	Oxycodone	To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.
Ibuprofen Group	Ibuprofen	To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.

Primary Outcome Measures

Name	Time	Method
Pain change/difference	180 minutes total	An appreciable change in pain scores (by 2 points) from presentation to discharge