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RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by IRCCS Burlo Garofolo.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT00560443
First received: November 7, 2007
Last updated: January 28, 2009
Last verified: January 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Fracture
Pain
 Drug: ketorolac
Drug: tramadol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on Effectiveness of Ketorolac and Tramadol in Not Compound Fractures of Child

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by IRCCS Burlo Garofolo:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560443

Contacts
Contact: Edoardo Guglia, md +390403785373 edigugl@gmail.com

Locations
Italy
IRCCS Burlo Garofolo Not yet recruiting
Trieste, Italy, 34100
Contact: gianni messi, md         messi@burlo.trieste.it    
Sub-Investigator: angela de cunto, md            
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
Principal Investigator: Edoardo Guglia, md IRCCS Burlo Garofolo
  More Information

No publications provided

Responsible Party: IRCCS Burlo Garofolo, Edoardo Guglia
ClinicalTrials.gov Identifier: NCT00560443     History of Changes
Other Study ID Numbers: RC 30/07
Study First Received: November 7, 2007
Last Updated: January 28, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS Burlo Garofolo:
bone fracture
ketorolac
tramadol

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Tramadol
Ketorolac
Ketorolac Tromethamine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013