Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department

Study Overview
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Brief Summary
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Acute low back pain is a common cause for emergency department visits. Controversy remains regarding the optimal medication for acute low back pain relief. The investigators hypothesized that administration of pharmacological anxiolysis in addition to analgesia will improve pain relief and patient management in the emergency department.

Detailed Description
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Acute low back pain is a common problem in the emergency department and pain relief is usually the first step in patients' management. Numerous medication options are available for acute LBP relief,each class of medication has its associated benefits and harms.Controversy remains regarding the optimal analgesic treatment.Anxiety has been found to be a predictive factor of pain intensity in patients with acute low back pain and anxiolysis by non-pharmacological measures has been shown to have a positive effect on pain management in the ED setting. Promethazine is a first-generation H1 receptor antagonist of the phenothiazine chemical class used commonly as an antihistamine antiemetic. It has a strong anxiolytic-sedative effect and its safety and efficacy in managing anxiety related to medical procedures is well documented.It may be reasonable to assume that pharmacological anxiolysis with promethazine may assist in alleviation of acute pain in the strenuous environment of the ED.

Official Title
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Pharmacological Anxiolysis With Promethazine as an Adjunctive Therapy for Acute Low Back Pain in the Adult Emergency Department

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Morphine-Promethazine
* Drug: morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An indication for opioid analgesia based in the ED (i.e. severe pain > 70mm on a 100mm VAS) Age between 18-65 years American Society of Anesthesiologists (ASA) score of 1 or 2, and no preexisting glaucoma, cardiac arrhythmia or pulmonary disease Systolic blood pressure higher than 90 mmHg on admission Willingness and ability to provide an informed consent No known hypersensitivity to the medication used. Exclusion Criteria: Pregnant women Patients who can not be under adult supervision following discharge from the emergency department.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morphine-Promethazine<br>Pain relief by administration of morphine-promethazine combination | Drug: Morphine-Promethazine<br>* administration of intravenous morphine 0.1mg/kg and promethazine 12.5 mg in a 500 Ml 0.9% saline<br>* Other names: morphine-phenergan;|
| Active Comparator: morphine<br>pain relief by administration of morphine | Drug: morphine<br>* Administration of intravenous morphine 0.1 mg/kg<br>* Other names: morphine as a single drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | Pain scores before and after treatment will be assessed on a 100mm VAS. The difference will be regarded as pain relief. | Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory status | Most patients who suffer from acute LBP are in severe pain and are unable to ambulate. The ambulatory status of every patient (e.g., able to walk independently, using a can, wheelchair, laying down and unable to sit or stand up)will be recorded before and after treatment. | Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain,, Emergency medicine,, Promethazine,, Morphine,, Pain relief