Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2016-05-31
2016-09-30
Brief Summary
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Detailed Description
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The patients will be randomised to receive either ketorolac 30 mg intravenous (diluted in 20 ml of 0,9% saline) or morphine 0,1 mg/kg weight intravenous. A scale of 1-10 will be used for measuring the pain, and the effects of the treatment will be evaluated at 15 minutes and 30 minutes from the administration of the drugs. After 30 minutes if there is no significant reduction of the pain a rescue therapy will be used : acetaminophen 1 g, sodic metamizole 1g both diluted in 500 ml saline and the other medication not used from the study (morphine or ketorolac tromethamine).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Ketorolac
The patients randomised to this arm will receive 30 mg intravenous ketorolac.
Morphine
The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.
Morphine
The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.
Ketorolac
The patients randomised to this arm will receive 30 mg intravenous ketorolac.
Interventions
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Ketorolac
The patients randomised to this arm will receive 30 mg intravenous ketorolac.
Morphine
The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.
Eligibility Criteria
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Inclusion Criteria
* grade 5 pain on a 1-10 visual pain scale
Exclusion Criteria
* pregnancy
* known allergies to ketorolac or opioids
* post-traumatic low back pain
* refusal of participation
18 Years
ALL
No
Sponsors
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Loredana Ghinea
OTHER
Responsible Party
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Loredana Ghinea
Medical Doctor
Principal Investigators
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Dan Marinescu, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Emergency Hospital Bucharest
Central Contacts
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Other Identifiers
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2-4627
Identifier Type: -
Identifier Source: org_study_id
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