Post-operative Oral Morphine Versus Ibuprofen

Study Overview
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Brief Summary
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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.

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

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: oral morphine
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ibuprofen<br>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. | Drug: Ibuprofen<br> <br> |
| Active Comparator: oral morphine<br>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. | Drug: oral morphine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in faces pain score pre and post intervention |  | 48 hours from the time of discharge from hospital. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral morphine, ibuprofen, post-operative pain