Post-operative Oral Morphine Versus Ibuprofen

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Naveen Poonai, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01686802
First received: September 13, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

Children 5-17 years of age who have undergo orthopedic day surgical procedures for definitive management of fractures, tendon release, etc. will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for 48 hours post-operatively at home. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in significantly lower pain scores on the Faces Pain Scale Revised (FPS-R) compared to ibuprofen. It is hoped that the results of this trial will create a new option for post-operative pain management in children.


Condition Intervention Phase
Post-operative Pain
Drug: oral morphine
Drug: Ibuprofen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Oral Morphine Versus Ibuprofen for Post-operative 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:
  • Change in faces pain score pre and post surgical intervention [ Time Frame: 48 hours from the time of discharge from hospital. ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ibuprofen
ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) from the time the patient is discharged from hospital as deemed by the physician to a maximum of 48 hours.
Drug: Ibuprofen
Active Comparator: oral morphine
oral morphine 0.5 mg/kg (max 20 mg) every 6 hours as needed for pain (maximum 4 doses) from the time the patient is discharged from hospital as deemed by the physician to a maximum of 48 hours.
Drug: oral morphine

  Eligibility

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

Inclusion Criteria:

  • all children aged 5-17 years who undergo an elective orthopedic or fracture-related surgical procedure at the Children's Hospital in London, Ontario and have a same-day discharge.

Exclusion Criteria:

  • known hypersensitivity to either ibuprofen or morphine
  • chronic users of NSAIDS or opioids
  • developmental delay
  • poor English fluency
  • pregnancy
  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: NCT01686802

Contacts
Contact: Naveen P C Poonai, MSc MD FRCPC 519-694-5309 poonai@hotmail.com

Locations
Canada, Ontario
London Health Science Center Not yet recruiting
London, Ontario, Canada, N6A 5W9
Principal Investigator: Naveen PC Poonai, MSc MD FRCPC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Naveen Poonai, MSc MD FRCPC Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Naveen Poonai, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01686802     History of Changes
Other Study ID Numbers: 102923
Study First Received: September 13, 2012
Last Updated: September 13, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
oral morphine
ibuprofen
post-operative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
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 01, 2014