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

May 23, 2010 updated by: Tel-Aviv Sourasky Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Tel-Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief
Time Frame: 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.
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
Time Frame: 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.
Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Study Chair: Pinchas Halpern, M.D, Tel-Aviv Medical Center, Tel-Aviv University, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

May 23, 2010

First Posted (Estimate)

May 25, 2010

Study Record Updates

Last Update Posted (Estimate)

May 25, 2010

Last Update Submitted That Met QC Criteria

May 23, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-09-PH-701-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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