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

Phase 4

• Conditions: Low Back Pain
• Interventions: Drug: Morphine-Promethazine; Drug: morphine

• Registration Number: NCT01129934
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-04-21
• Status Verified: 2010-05
• Study Start: 2010-05
• Study First Submitted QC: 2010-05-23
• Last Update Submitted: 2010-05-23
• Study First Posted: 2010-05-25
• Last Update Posted: 2010-05-25
• Primary Completion: 2011-12
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine-Promethazine	Morphine-Promethazine	Pain relief by administration of morphine-promethazine combination
morphine	morphine	pain relief by administration of morphine

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ambulatory status	Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)	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.

Trial Locations

Locations (1)

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel