RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Burlo Garofolo
• Treatments: Ketorolac; Ketorolac Tromethamine; Tramadol

Criteria

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