RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

IRCCS Burlo Garofolo133 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

133

Conditions

Fracture Pain

Interventions

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 6 hours (or until the end of procedures)

Secondary Outcomes

comparison between the two groups on effectiveness on pain, measured with linear and analogic scale (see above)

Time frame: 6 hours or until the end of procedures