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

The Washington University

Status: Withdrawn

Conditions: Forearm Injuries; Pain, Acute; Pediatric ALL

Treatments: Drug: Ibuprofen; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT04523623

OxyvsIbup2020

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Ibuprofen Group

Experimental group

Description:

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

Treatment:

Drug: Ibuprofen

Oxycodone Group

Experimental group

Description:

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

Treatment:

Drug: Oxycodone