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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
Sponsor:
Information provided by (Responsible Party):
Loredana Ghinea, Bucharest Emergency Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Ketorolac Drug: Morphine Phase 4

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Analgesic Effects of Morphine Versus Ketorolac in Low Back Pain
Study Start Date : May 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ketorolac
The patients randomised to this arm will receive 30 mg intravenous ketorolac.
 Drug: Morphine
The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.
Active Comparator: Morphine
The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.
 Drug: Ketorolac
The patients randomised to this arm will receive 30 mg intravenous ketorolac.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time of staying in emergency department [ Time Frame: 30 minutes, 1 hour, 2 hours, 3 hours ]
  2. The necessity neurosurgery consult - questionnaire [ Time Frame: 1 month ]
    The patients will be called after 1 month to see if they needed an appointment with the neurosurgeon.

  3. The cost of each treatment [ Time Frame: 1 hour ]
  4. The necessity to use rescue therapy [ Time Frame: 30 minutes ]
    30 minutes from presentation in the ED - if the pain is still > 5 on a 1-10 scale

  5. Side effects of each treatment [ Time Frame: 30 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of musculoskeletal low back pain
  • grade 5 pain on a 1-10 visual pain scale

Exclusion Criteria:

  • contraindications of ketorolac or opioids
  • pregnancy
  • known allergies to ketorolac or opioids
  • post-traumatic low back pain
  • refusal of participation
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02782286


Contacts
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Contact: Dan Marinescu, MD 0040741020848 danvmarinescu@gmail.com
Contact: Vlad A Maltezeanu, MD 0040720943180 vladmaltezeanu@yahoo.co.uk

Sponsors and Collaborators
Loredana Ghinea
Investigators
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Principal Investigator: Dan Marinescu, MD Clinical Emergency Hospital Bucharest
More Information
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Responsible Party: Loredana Ghinea, Medical Doctor, Bucharest Emergency Hospital
ClinicalTrials.gov Identifier: NCT02782286    
Other Study ID Numbers: 2-4627
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Loredana Ghinea, Bucharest Emergency Hospital:
ketorolac
pain relieve
morphine
Additional relevant MeSH terms:
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Ketorolac
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
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