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Completed

NCT Number: NCT00560443

RCT on Ketorolac and Tramadol in Bone Fractures Pain 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

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Key information

Conditions

Fracture Fractures, Bone Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IRCCS Burlo Garofolo

Trieste, 34100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

0,5 mg/kg per os one time

Tramadol

Drug

2,5 mg/ kg per os in one dose

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2007
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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