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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

Tracking Information
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
 (submitted: May 22, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2016)
  • Time of staying in emergency department [ Time Frame: 30 minutes, 1 hour, 2 hours, 3 hours ]
  • 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.
  • The cost of each treatment [ Time Frame: 1 hour ]
  • 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
  • Side effects of each treatment [ Time Frame: 30 minutes ]
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).

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
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Drug: 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.
Study Arms  ICMJE
  • Active Comparator: Ketorolac
    The patients randomised to this arm will receive 30 mg intravenous ketorolac.
    Intervention: Drug: Morphine
  • Active Comparator: Morphine
    The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.
    Intervention: Drug: Ketorolac
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 22, 2016)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Plan to Share IPD: Undecided
Responsible Party Loredana Ghinea, Bucharest Emergency Hospital
Study Sponsor  ICMJE Loredana Ghinea
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dan Marinescu, MD Clinical Emergency Hospital Bucharest
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