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| 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:
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: | 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Edoardo Guglia, md | +390403785373 | edigugl@gmail.com |
| Italy | |
| IRCCS Burlo Garofolo | Not yet recruiting |
| Trieste, Italy, 34100 | |
| Contact: gianni messi, md messi@burlo.trieste.it | |
| Sub-Investigator: angela de cunto, md | |
| Principal Investigator: | Edoardo Guglia, md | IRCCS Burlo Garofolo |
More Information
| 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 |
|
bone fracture ketorolac tramadol |
|
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 |
