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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac | Active Comparator | The patients randomised to this arm will receive 30 mg intravenous ketorolac. |
|
| Morphine | Active Comparator | The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | The patients randomised to this arm will receive 30 mg intravenous ketorolac. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reducing the grade of pain | To see the reducing of the pain on a scale 1-10 at two time points | 15 minutes, 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time of staying in emergency department | 30 minutes, 1 hour, 2 hours, 3 hours | |
| The necessity neurosurgery consult - questionnaire | The patients will be called after 1 month to see if they needed an appointment with the neurosurgeon. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Marinescu, MD | Contact | 0040741020848 | danvmarinescu@gmail.com | |
| Vlad A Maltezeanu, MD | Contact | 0040720943180 | vladmaltezeanu@yahoo.co.uk |
| Name | Affiliation | Role |
|---|---|---|
| Dan Marinescu, MD | Clinical Emergency Hospital Bucharest | Principal Investigator |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Morphine |
| Drug |
The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine. |
|
| 1 month |
| The cost of each treatment | 1 hour |
| The necessity to use rescue therapy | 30 minutes from presentation in the ED - if the pain is still > 5 on a 1-10 scale | 30 minutes |
| Side effects of each treatment | 30 minutes |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |