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

Oxycodone or Ibuprofen for Suspected Isolated Forearm Fractures in Pediatric Patients: A Randomized Noninferiority Trial

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04523623

Enrollment

Registered

2020-08-21

Start date

2020-07-28

Completion date

2021-06-21

Last updated

2024-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Forearm Injuries, Pain, Acute, Pediatric ALL

Keywords

oxycodone, ibuprofen

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.

Interventions

DRUGOxycodone

oxycodone 0.2mg/kg, max 10mg to be administered, randomized between that and Ibuprofen

DRUGIbuprofen

ibuprofen 10mg/kg, max 800mg, randomized between that and Oxycodone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026