RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child
- Registration Number
- NCT00560443
- Lead Sponsor
- IRCCS Burlo Garofolo
- Brief Summary
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:
* 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
Inclusion Criteria
- Children 4-17 years old with not compound bone fracture presenting in emergency room
Exclusion Criteria
- Compound fracture
- Occurring pain still treated
- Contraindicated ketorolac or tramadol use
- Informed consensus not obtained
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ketorolac children 4-17 y. old with not compound bone fracture treated with ketorolac 2 tramadol children 4-17 y. old with not compound bone fracture treated with tramadol
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
IRCCS Burlo Garofolo
🇮🇹Trieste, Italy