Morphine Versus Ketorolac in Low Back Pain
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ClinicalTrials.gov Identifier: NCT02782286 |
Recruitment Status : Unknown
Verified May 2016 by Loredana Ghinea, Bucharest Emergency Hospital.
Recruitment status was: Not yet recruiting
First Posted : May 25, 2016
Last Update Posted : May 25, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | May 16, 2016 | |||
First Posted Date ICMJE | May 25, 2016 | |||
Last Update Posted Date | May 25, 2016 | |||
Study Start Date ICMJE | May 2016 | |||
Estimated Primary Completion Date | September 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Reducing the grade of pain [ Time Frame: 15 minutes, 30 minutes ] To see the reducing of the pain on a scale 1-10 at two time points
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Morphine Versus Ketorolac in Low Back Pain | |||
Official Title ICMJE | The Analgesic Effects of Morphine Versus Ketorolac in Low Back Pain | |||
Brief Summary | The study is prospective, double blinded, randomised controlled and has the purpose to compare the analgesic effects of ketorolac or morphine intravenous in low back pain. | |||
Detailed Description | The study will take place in the Emergency Department of the Clinical Emergency Hospital Bucharest and will compare the analgesic effects of ketorolac tromethamine against morphine in low back pain. 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). |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Low Back Pain | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
100 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | September 2016 | |||
Estimated Primary Completion Date | September 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02782286 | |||
Other Study ID Numbers ICMJE | 2-4627 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Loredana Ghinea, Bucharest Emergency Hospital | |||
Study Sponsor ICMJE | Loredana Ghinea | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Bucharest Emergency Hospital | |||
Verification Date | May 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |