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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Forearm Injuries, Pain, Acute, Pediatric ALL

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 to 17 year old children presenting for care in the St. Louis Children's Hospital Emergency Department Suspected acute (within 24 hours) isolated forearm fracture at the time of initial Triage assessment American Society of Anesthesiologist physical status (ASA-PS) classification of I or II Child with parent or legal guardian. Exclusion Criteria: Multiple injuries Known adverse reaction to either ibuprofen or oxycodone pts with abnormal bones or metabolic conditions that affect bones Administration of any opioid within 2 hours prior to presentation Non-English speaking Foster care, police custody, presenting without legal guardian

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen Group<br>To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children. | Drug: Ibuprofen<br>* ibuprofen 10mg/kg, max 800mg, randomized between that and Oxycodone<br>|
| Experimental: Oxycodone Group<br>To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children. | Drug: Oxycodone<br>* oxycodone 0.2mg/kg, max 10mg to be administered, randomized between that and Ibuprofen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | An appreciable decrease in pain scores (2 point reduction) from presentation to discharge | 180 minutes total | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxycodone, ibuprofen