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Post-operative Oral Morphine Versus Ibuprofen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naveen Poonai, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01686802
First received: September 13, 2012
Last updated: December 27, 2016
Last verified: December 2016
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 Naveen Poonai, Lawson Health Research Institute:

Primary Outcome Measures:
  • Change in faces pain score pre and post intervention [ Time Frame: 48 hours from the time of discharge from hospital. ]

Secondary Outcome Measures:
  • Change in faces pain score pre and post intervention [ Time Frame: 48 hours from the time of discharge from hospital ]
    Second to eighth doses of intervention

  • Adverse effects [ Time Frame: 96 hours from first dose of intervention ]
  • Number of participants requiring acetaminophen for breakthrough pain [ Time Frame: 48 hours from first dose of intervention ]
  • Unscheduled visits to a health care provider for pain [ Time Frame: 96 hours from first dose of intervention ]

Enrollment: 132
Study Start Date: September 2012
Study Completion Date: September 2016
Primary Completion Date: September 2016 (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 8 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 8 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   (Child)
Sexes Eligible for Study:   All
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
  • cognitive impairment
  • poor English fluency
  • pregnancy
  • acute or chronic renal insufficiency
  • bleeding disorder
  • obstructive sleep apnea
  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

Locations
Canada, Ontario
London Health Science Center
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Naveen Poonai, MSc MD FRCPC Lawson Health Research Institute
  More Information

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: December 27, 2016

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Morphine
Ibuprofen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
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

ClinicalTrials.gov processed this record on June 26, 2017