Post-operative Oral Morphine Versus Ibuprofen

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

132

Conditions

Post-operative Pain

Interventions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in faces pain score pre and post intervention

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

Secondary Outcomes

Change in faces pain score pre and post intervention

Second to eighth doses of intervention

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

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