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

Sponsored by:	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

MedlinePlus related topics: Fractures

Drug Information available for: Tramadol hydrochloride Tramadol Ketorolac Ketorolac tromethamine

U.S. FDA Resources

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

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) ]

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 ]

Estimated Enrollment:	120
Study Start Date:	February 2008
Estimated Study Completion Date:	October 2010

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

Study ID Numbers:	RC 30/07
Study First Received:	November 7, 2007
Last Updated:	November 16, 2007
ClinicalTrials.gov Identifier:	NCT00560443
Health Authority:	Italy: Ethics Committee

Keywords provided by IRCCS Burlo Garofolo:

bone fracture
ketorolac
tramadol

Study placed in the following topic categories:

Tramadol
Ketorolac
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Fractures, Open
Pain
Ketorolac Tromethamine

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Narcotics
Pharmacologic Actions
Sensory System Agents

Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 15, 2009