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

Tel-Aviv Sourasky Medical Center200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Low Back Pain

Interventions

Morphine-PromethazineDRUG

administration of intravenous morphine 0.1mg/kg and promethazine 12.5 mg in a 500 Ml 0.9% saline

morphineDRUG

Administration of intravenous morphine 0.1 mg/kg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. An indication for opioid analgesia based in the ED (i.e. severe pain \> 70mm on a 100mm VAS) 2. Age between 18-65 years 3. American Society of Anesthesiologists (ASA) score of 1 or 2, and no preexisting glaucoma, cardiac arrhythmia or pulmonary disease 4. Systolic blood pressure higher than 90 mmHg on admission 5. Willingness and ability to provide an informed consent 6. No known hypersensitivity to the medication used. Exclusion Criteria: 1. Pregnant women 2. Patients who can not be under adult supervision following discharge from the emergency department.

Locations (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Outcomes

Primary Outcomes

Pain relief

Pain scores before and after treatment will be assessed on a 100mm VAS. The difference will be regarded as pain relief.

Time frame: Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)

Secondary Outcomes

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.

Time frame: Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)

Central Contacts

Ofir Uri, M.D

CONTACT

972-52-4262285 ofiruri@gmail.com

Data from ClinicalTrials.gov

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