RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

August 23, 2017 updated by: IRCCS Burlo Garofolo

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Trieste, Italy, 34100
        • IRCCS Burlo Garofolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
children 4-17 y. old with not compound bone fracture treated with ketorolac
Drug: ketorolac
0,5 mg/kg per os one time
Experimental: 2
children 4-17 y. old with not compound bone fracture treated with tramadol
Drug: tramadol
2,5 mg/ kg per os in one dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
6 hours (or until the end of procedures)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 hours or until the end of procedures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Burlo Garofolo

Investigators

  • Principal Investigator: Edoardo Guglia, md, IRCCS Burlo Garofolo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

November 7, 2007

First Submitted That Met QC Criteria

November 16, 2007

First Posted (Estimate)

November 19, 2007

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 30/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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