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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-28

Study Completion Date

2021-06-21

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.

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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.

Conditions

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Forearm Injuries Pain, Acute Pediatric ALL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ibuprofen Group

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

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

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

Oxycodone Group

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

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

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

Interventions

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Oxycodone

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

Intervention Type DRUG

Ibuprofen

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No