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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Condition or disease | Intervention/treatment | Phase |
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Low Back Pain | Drug: Ketorolac Drug: Morphine | Phase 4 |
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 : | 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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Ketorolac
The patients randomised to this arm will receive 30 mg intravenous ketorolac.
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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.
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Drug: Ketorolac
The patients randomised to this arm will receive 30 mg intravenous ketorolac. |
- 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
- 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 ]

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

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
Contact: Dan Marinescu, MD | 0040741020848 | danvmarinescu@gmail.com | |
Contact: Vlad A Maltezeanu, MD | 0040720943180 | vladmaltezeanu@yahoo.co.uk |
Principal Investigator: | Dan Marinescu, MD | Clinical Emergency Hospital Bucharest |
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 |
ketorolac pain relieve morphine |
Ketorolac Back Pain Low Back Pain Pain Neurologic Manifestations 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 |