Oral Morphine Versus Ibuprofen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01690780
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):
Naveen Poonai, Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Upper Extremity Fractures Analgesia Post Fracture Drug: Oral morphine Drug: Ibuprofen Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study
Study Start Date : September 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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

Primary Outcome Measures :
  1. Faces Pain scale - revised [ Time Frame: 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 :
  1. Acetaminophen doses [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01690780

Canada, Ontario
London Health Sciences Center
London, Ontario, Canada, N6A5W9
Sponsors and Collaborators
Naveen Poonai
Principal Investigator: Naveen Poonai, MD, FRCPC Lawson Health Research Institute

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Naveen Poonai, Principal Investigator, Lawson Health Research Institute Identifier: NCT01690780     History of Changes
Other Study ID Numbers: R-11-340
18091 ( Other Identifier: REB )
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Keywords provided by Naveen Poonai, Lawson Health Research Institute:
oral morphine

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action