Oral Morphine Versus Ibuprofen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naveen Poonai, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01690780
First received: September 13, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention
Upper Extremity Fractures
Analgesia Post Fracture
Drug: Oral morphine
Drug: Ibuprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Faces Pain scale - revised [ Time Frame: 30 minutes post intervention compared to baseline ] [ Designated as safety issue: No ]
    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:
  • Acetaminophen doses [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The secondary outcome variable is the number of breakthrough acetaminophen doses required/taken by the participant for the first 24 hours post-fracture management


Enrollment: 183
Study Start Date: September 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690780

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

No publications provided

Responsible Party: Naveen Poonai, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01690780     History of Changes
Other Study ID Numbers: R-11-340, 18091
Study First Received: September 13, 2012
Last Updated: July 15, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
fracture
pediatric
oral morphine
ibuprofen

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

ClinicalTrials.gov processed this record on August 28, 2014