Oral Morphine Versus Ibuprofen

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

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-02-28

Brief Summary

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Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for the first 24 hours following discharge from the emergency department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in greater pain relief than ibuprofen.

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Detailed Description

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Conditions

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Upper Extremity Fractures Analgesia Post Fracture

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 Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department

Oral morphine

Group Type EXPERIMENTAL

Oral morphine

Intervention Type DRUG

oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours

Interventions

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Oral morphine

oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours

Intervention Type DRUG

Ibuprofen

Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture

Exclusion Criteria

* patients with known hypersensitivity to either ibuprofen or morphine
* chronic users of NSAIDS or opioids
* fractures requiring operative management
* associated injuries requiring analgesia
* poor English fluency
* pregnancy

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes