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| ID | Type | Description | Link |
|---|---|---|---|
| 18091 | Other Identifier | REB |
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Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for the first 24 hours following discharge from the emergency department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in greater pain relief than ibuprofen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Active Comparator |
| |
| Oral morphine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral morphine | Drug | oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Faces Pain scale - revised | The primary outcome variable is the pre-post intervention difference in pain scores as measured by self-reported Faces Pain Scale - Revised (FPS-R) for the first 24 hours post-fracture management following the as needed administration of the study drugs. | 30 minutes post intervention compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Acetaminophen doses | The secondary outcome variable is the number of breakthrough acetaminophen doses required/taken by the participant for the first 24 hours post-fracture management | 24 hours |
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Exclusion Criteria:
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naveen Poonai, 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 Sciences Center | London | Ontario | N6A5W9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41630937 | Derived | Faught L, Elzagallaai AA, Tonial N, Ali S, Lepore N, Reardon J, Urquhart B, Ross C, Rieder MJ, Poonai N. Oral morphine pharmacokinetics in healthy children and the effect of genetic polymorphisms: An exploratory study. Paediatr Child Health. 2025 Oct 12;31(1):35-41. doi: 10.1093/pch/pxaf084. eCollection 2026 Feb. | |
| 25349008 | Derived |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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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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| Ibuprofen | Drug | Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department |
|
| Poonai N, Bhullar G, Lin K, Papini A, Mainprize D, Howard J, Teefy J, Bale M, Langford C, Lim R, Stitt L, Rieder MJ, Ali S. Oral administration of morphine versus ibuprofen to manage postfracture pain in children: a randomized trial. CMAJ. 2014 Dec 9;186(18):1358-63. doi: 10.1503/cmaj.140907. Epub 2014 Oct 27. |
| 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 |