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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ibuprofen | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral morphine | Drug |
| ||
| Ibuprofen |
| Measure | Description | Time Frame |
|---|---|---|
| Change in faces pain score pre and post intervention | 48 hours from the time of discharge from hospital. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naveen Poonai, MSc MD FRCPC | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Science Center | London | Ontario | N6A 5W9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29018084 | Derived | Poonai N, Datoo N, Ali S, Cashin M, Drendel AL, Zhu R, Lepore N, Greff M, Rieder M, Bartley D. Oral morphine versus ibuprofen administered at home for postoperative orthopedic pain in children: a randomized controlled trial. CMAJ. 2017 Oct 10;189(40):E1252-E1258. doi: 10.1503/cmaj.170017. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |