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

IRCCS Burlo Garofolo1 site in 1 country133 target enrollmentFebruary 2008

ConditionsFracture Pain

Interventionsketorolac tramadol

Drugsketorolac tramadol

Overview

Phase: Phase 4
Intervention: ketorolac
Conditions: Fracture
Sponsor: IRCCS Burlo Garofolo
Enrollment: 133
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

April 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

IRCCS Burlo Garofolo

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

1

children 4-17 y. old with not compound bone fracture treated with ketorolac

Intervention: ketorolac

2

children 4-17 y. old with not compound bone fracture treated with tramadol

Intervention: tramadol

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)(6 hours or until the end of procedures)