Fracture, Pain
Conditions
Keywords
bone fracture, ketorolac, tramadol
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
Interventions
DRUGketorolac
0,5 mg/kg per os one time
DRUGtramadol
2,5 mg/ kg per os in one dose
Sponsors
IRCCS Burlo Garofolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | 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 |
Countries
Italy
Outcome results
None listed