Skip to main content
OpenTrials
Completed

NCT Number: NCT01686802

Post-operative Oral Morphine Versus Ibuprofen

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London Health Science Center

London, Ontario, N6A 5W9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral morphine

Drug

Ibuprofen

Drug

Primary outcomes

  1. Change in faces pain score pre and post intervention

    Time frame: 48 hours from the time of discharge from hospital.

Secondary outcomes

  1. 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

  2. Adverse effects

    Time frame: 96 hours from first dose of intervention

  3. Number of participants requiring acetaminophen for breakthrough pain

    Time frame: 48 hours from first dose of intervention

  4. Unscheduled visits to a health care provider for pain

    Time frame: 96 hours from first dose of intervention

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2012
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.