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