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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01686802
Other study ID # 102923
Secondary ID
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


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
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