RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child - Full Text View

Sponsor:	IRCCS Burlo Garofolo
Information provided by:	IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:	NCT00560443

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: Tramadol Ketorolac Ketorolac tromethamine

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
1: Active Comparator children 4-17 y. old with not compound bone fracture treated with ketorolac	Drug: ketorolac 0,5 mg/kg per os one time
2: Experimental 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
Trieste, Italy, 34100

Sponsors and Collaborators

IRCCS Burlo Garofolo

Investigators

Principal Investigator:

Edoardo Guglia, md

IRCCS Burlo Garofolo

More Information

No publications provided

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

Keywords provided by IRCCS Burlo Garofolo:

bone fracture
ketorolac
tramadol

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Tramadol
Cyclooxygenase Inhibitors
Fractures, Bone
Ketorolac
Physiological Effects of Drugs
Wounds and Injuries
Central Nervous System Depressants
Disorders of Environmental Origin
Enzyme Inhibitors
Narcotics

Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Ketorolac Tromethamine
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010