RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00560443
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : August 24, 2017
Information provided by (Responsible Party):
IRCCS Burlo Garofolo

Brief Summary:

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 or disease Intervention/treatment Phase
Fracture Pain Drug: ketorolac Drug: tramadol Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on Effectiveness of Ketorolac and Tramadol in Not Compound Fractures of Child
Actual Study Start Date : February 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00560443

IRCCS Burlo Garofolo
Trieste, Italy, 34100
Sponsors and Collaborators
IRCCS Burlo Garofolo
Principal Investigator: Edoardo Guglia, md IRCCS Burlo Garofolo

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: IRCCS Burlo Garofolo Identifier: NCT00560443     History of Changes
Other Study ID Numbers: RC 30/07
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Keywords provided by IRCCS Burlo Garofolo:
bone fracture

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