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Randomized double blind Trial with the aim to estimate effectiveness of two therapeutic regimes per os on pain due to not compound bone fractures in child 4-17 years old:
Intensity of pain will be estimated with linear 1 to 10 or analogic McGrath type scale every 20 min.
The main objectives are the evaluation of pain decreasing in every group, the time of decreasing, the intensity of pain during procedures (ex. Xray) and the occurrence of side effects Secondary outcomes are comparison between the two groups on effectiveness on pain and on side effects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | children 4-17 y. old with not compound bone fracture treated with ketorolac |
|
| 2 | Experimental | children 4-17 y. old with not compound bone fracture treated with tramadol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketorolac | Drug | 0,5 mg/kg per os one time |
| |
| tramadol |
| Measure | Description | Time Frame |
|---|---|---|
| estimation of pain reduction in every arm of the trial with linear 1-10 pain scale or for children 4 - 6 years old with analogic MacGrath type scale | 6 hours (or until the end of procedures) |
| Measure | Description | Time Frame |
|---|---|---|
| comparison between the two groups on effectiveness on pain, measured with linear and analogic scale (see above) | 6 hours or until the end of procedures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edoardo Guglia, md | IRCCS Burlo Garofolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Burlo Garofolo | Trieste | 34100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23702435 | Derived | Neri E, Maestro A, Minen F, Montico M, Ronfani L, Zanon D, Favret A, Messi G, Barbi E. Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone pain in children: a double-blind, randomised, controlled trial. Arch Dis Child. 2013 Sep;98(9):721-4. doi: 10.1136/archdischild-2012-303527. Epub 2013 May 23. |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
2,5 mg/ kg per os in one dose |
|
| D006571 | Heterocyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |