Oral Morphine Versus Ibuprofen

Not Applicable

Completed

• Conditions: Upper Extremity Fractures; Analgesia Post Fracture
• Interventions: Drug: Oral morphine; Drug: Ibuprofen

• Registration Number: NCT01690780
• Lead Sponsor: Naveen Poonai

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-24
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral morphine	Oral morphine	-
Ibuprofen	Ibuprofen	-

Primary Outcome Measures

Name	Time	Method
Faces Pain scale - revised	30 minutes post intervention compared to baseline	The primary outcome variable is the pre-post intervention difference in pain scores as measured by self-reported Faces Pain Scale - Revised (FPS-R) for the first 24 hours post-fracture management following the as needed administration of the study drugs.

Secondary Outcome Measures

Name	Time	Method
Acetaminophen doses	24 hours	The secondary outcome variable is the number of breakthrough acetaminophen doses required/taken by the participant for the first 24 hours post-fracture management

Trial Locations

Locations (1)

London Health Sciences Center; 🇨🇦 London, Ontario, Canada