drugset / Trial / NCT00560443

RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

NCT00560443

Phase 4 Completed 133 enrolled IRCCS Burlo Garofolo
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2008-02
Primary completion
2012-04
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketorolac Other / unclassified 0.5 mg/kg Oral
Subject Tramadol Other / unclassified 2.5 mg/kg Oral

Indications

No indication recorded.