RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child
NCT ID: NCT00560443
Last Updated: 2017-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
133 participants
INTERVENTIONAL
2008-02-29
2012-04-30
Brief Summary
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* ketorolac 0,5 mg/kg (1 drop every 2 Kg)
* tramadol 2,5 mg/Kh (1 drop every 2 Kg)
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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
children 4-17 y. old with not compound bone fracture treated with ketorolac
ketorolac
0,5 mg/kg per os one time
2
children 4-17 y. old with not compound bone fracture treated with tramadol
tramadol
2,5 mg/ kg per os in one dose
Interventions
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ketorolac
0,5 mg/kg per os one time
tramadol
2,5 mg/ kg per os in one dose
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Occurring pain still treated
* Contraindicated ketorolac or tramadol use
* Informed consensus not obtained
4 Years
17 Years
ALL
No
Sponsors
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IRCCS Burlo Garofolo
OTHER
Responsible Party
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Principal Investigators
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Edoardo Guglia, md
Role: PRINCIPAL_INVESTIGATOR
IRCCS Burlo Garofolo
Locations
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IRCCS Burlo Garofolo
Trieste, , Italy
Countries
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References
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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.
Other Identifiers
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RC 30/07
Identifier Type: -
Identifier Source: org_study_id
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