Post-operative Oral Morphine Versus Ibuprofen

Phase 2

Completed

• Conditions: Post-operative Pain
• Interventions: Drug: Ibuprofen; Drug: oral morphine

• Registration Number: NCT01686802
• Lead Sponsor: Lawson Health Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-13
• Study First Posted: 2012-09-18
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-27
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ibuprofen	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.
oral morphine	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.

Primary Outcome Measures

Name	Time	Method
Change in faces pain score pre and post intervention	48 hours from the time of discharge from hospital.

Secondary Outcome Measures

Name	Time	Method
Change in faces pain score pre and post intervention	48 hours from the time of discharge from hospital	Second to eighth doses of intervention
Number of participants requiring acetaminophen for breakthrough pain	48 hours from first dose of intervention
Adverse effects	96 hours from first dose of intervention
Unscheduled visits to a health care provider for pain	96 hours from first dose of intervention

Trial Locations

Locations (1)

London Health Science Center; 🇨🇦 London, Ontario, Canada