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Morphine Versus Ketorolac in Low Back Pain

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketorolac
Morphine
Sponsored by
Loredana Ghinea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring ketorolac, pain relieve, morphine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ketorolac

    Morphine

    Arm Description

    The patients randomised to this arm will receive 30 mg intravenous ketorolac.

    The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.

    Outcomes

    Primary Outcome Measures

    Reducing the grade of pain
    To see the reducing of the pain on a scale 1-10 at two time points

    Secondary Outcome Measures

    Time of staying in emergency department
    The necessity neurosurgery consult - questionnaire
    The patients will be called after 1 month to see if they needed an appointment with the neurosurgeon.
    The cost of each treatment
    The necessity to use rescue therapy
    30 minutes from presentation in the ED - if the pain is still > 5 on a 1-10 scale
    Side effects of each treatment

    Full Information

    First Posted
    May 16, 2016
    Last Updated
    May 22, 2016
    Sponsor
    Loredana Ghinea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02782286
    Brief Title
    Morphine Versus Ketorolac in Low Back Pain
    Official Title
    The Analgesic Effects of Morphine Versus Ketorolac in Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    September 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Loredana Ghinea

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    ketorolac, pain relieve, morphine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ketorolac
    Arm Type
    Active Comparator
    Arm Description
    The patients randomised to this arm will receive 30 mg intravenous ketorolac.
    Arm Title
    Morphine
    Arm Type
    Active Comparator
    Arm Description
    The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketorolac
    Intervention Description
    The patients randomised to this arm will receive 30 mg intravenous ketorolac.
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine
    Intervention Description
    The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.
    Primary Outcome Measure Information:
    Title
    Reducing the grade of pain
    Description
    To see the reducing of the pain on a scale 1-10 at two time points
    Time Frame
    15 minutes, 30 minutes
    Secondary Outcome Measure Information:
    Title
    Time of staying in emergency department
    Time Frame
    30 minutes, 1 hour, 2 hours, 3 hours
    Title
    The necessity neurosurgery consult - questionnaire
    Description
    The patients will be called after 1 month to see if they needed an appointment with the neurosurgeon.
    Time Frame
    1 month
    Title
    The cost of each treatment
    Time Frame
    1 hour
    Title
    The necessity to use rescue therapy
    Description
    30 minutes from presentation in the ED - if the pain is still > 5 on a 1-10 scale
    Time Frame
    30 minutes
    Title
    Side effects of each treatment
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dan Marinescu, MD
    Phone
    0040741020848
    Email
    danvmarinescu@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vlad A Maltezeanu, MD
    Phone
    0040720943180
    Email
    vladmaltezeanu@yahoo.co.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dan Marinescu, MD
    Organizational Affiliation
    Clinical Emergency Hospital Bucharest
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Morphine Versus Ketorolac in Low Back Pain

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