Morphine Versus Ketorolac in Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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The Analgesic Effects of Morphine Versus Ketorolac in Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketorolac<br>The patients randomised to this arm will receive 30 mg intravenous ketorolac. | Drug: Morphine<br>* The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.<br>|
| Active Comparator: Morphine<br>The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine. | Drug: Ketorolac<br>* The patients randomised to this arm will receive 30 mg intravenous ketorolac.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketorolac, pain relieve, morphine