Not compound fractures in childhood. MedDRA version: 9.1 Level: HLGT Classification code 10017322 Term: Fractures
Conditions
Interventions
Product Name: Ketorolac
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Ketorolac
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Sponsors
ISTITUTO PER L'INFANZIA BURLO GAROFOLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: After obtainance of informed consensus from legal tutors, all the children between 4 and 17 years presenting in Emergency room in the next two years with a not compound, but not exponed fracture, will be enrolled, with a extimation of 120 patients at the end of the study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Occuring pain still treated. Informed consensus not obtained. Controindicated Ketorolac or Tramadole use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a randomized double blind trial with the aim to estimate the effectiveness of two therapeutic regimes per os on pain due to not compound bone fractures in child: a) ketorolac 0,5 mg/kg (1 drop every 2 Kg) b) tramadole 2,5 mg/Kg (1 drop every 2 kg). Intensity of pain will be extimated 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 and the occurrence of side effects.;Secondary Objective: Comparison between the two groups on the effectiveness on pain and on side effects.;Primary end point(s): Extimation of pain reduction in every arms of the trial. | — |
Countries
Italy
Outcome results
None listed