Post-operative Oral Morphine Versus Ibuprofen

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686802
• Other study ID #: 102923
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2012
• Last updated: December 27, 2016
• Start date: September 2012
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• oral morphine

• Ibuprofen

Locations

Country	Name	City	State
Canada	London Health Science Center	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in faces pain score pre and post intervention		48 hours from the time of discharge from hospital.	No
Secondary	Change in faces pain score pre and post intervention	Second to eighth doses of intervention	48 hours from the time of discharge from hospital	No
Secondary	Adverse effects		96 hours from first dose of intervention	Yes
Secondary	Number of participants requiring acetaminophen for breakthrough pain		48 hours from first dose of intervention	No
Secondary	Unscheduled visits to a health care provider for pain		96 hours from first dose of intervention	Yes