NCT00560443

RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

Randomized Controlled Trial on Effectiveness of Ketorolac and Tramadol in Not Compound Fractures of Child

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• Fracture
• Pain

Interventions

Type	Name	Description
DRUG	ketorolac	0,5 mg/kg per os one time
DRUG	tramadol	2,5 mg/ kg per os in one dose

Timeline

• Start date: 2008-02-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2007-11-19
• Last updated: 2017-08-24

Locations

1 site across 1 country: Italy