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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Oral Morphine Versus Ibuprofen for Post-operative Pain Management in Children: a Randomized Controlled Study|
- Change in faces pain score pre and post surgical intervention [ Time Frame: 48 hours from the time of discharge from hospital. ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Active Comparator: ibuprofen
ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) from the time the patient is discharged from hospital as deemed by the physician to a maximum of 48 hours.
Active Comparator: oral morphine
oral morphine 0.5 mg/kg (max 20 mg) every 6 hours as needed for pain (maximum 4 doses) from the time the patient is discharged from hospital as deemed by the physician to a maximum of 48 hours.
|Drug: oral morphine|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686802
|Contact: Naveen P C Poonai, MSc MD FRCPCfirstname.lastname@example.org|
|London Health Science Center||Recruiting|
|London, Ontario, Canada, N6A 5W9|
|Principal Investigator: Naveen PC Poonai, MSc MD FRCPC|
|Principal Investigator:||Naveen Poonai, MSc MD FRCPC||Lawson Health Research Institute|