Oral Morphine Versus Ibuprofen

Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Upper Extremity Fractures; Analgesia Post Fracture
• Intervention / Treatment: Drug: Ibuprofen; Drug: Oral morphine

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5W9
      • London Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ibuprofen	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
Experimental: Oral morphine	Drug: Oral morphine; oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faces Pain scale - revised	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.	30 minutes post intervention compared to baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Naveen Poonai
• Investigators: Principal Investigator: Naveen Poonai, MD, FRCPC, Lawson Health Research Institute

Publications and helpful links

General Publications

• Poonai N, Bhullar G, Lin K, Papini A, Mainprize D, Howard J, Teefy J, Bale M, Langford C, Lim R, Stitt L, Rieder MJ, Ali S. Oral administration of morphine versus ibuprofen to manage postfracture pain in children: a randomized trial. CMAJ. 2014 Dec 9;186(18):1358-63. doi: 10.1503/cmaj.140907. Epub 2014 Oct 27.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: September 13, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 24, 2012

Study Record Updates

• Last Update Posted (Estimate): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 15, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: pediatric; ibuprofen; fracture; oral morphine
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Morphine; Ibuprofen
• Other Study ID Numbers: R-11-340; 18091 (Other Identifier: REB)