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

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ClinicalTrials.gov Identifier: NCT01129934
Recruitment Status : Unknown
Verified May 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2010
Last Update Posted : May 25, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Morphine-Promethazine Drug: morphine Phase 4

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Pharmacological Anxiolysis With Promethazine as an Adjunctive Therapy for Acute Low Back Pain in the Adult Emergency Department
Study Start Date : May 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : January 2013

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 Name: morphine-phenergan
Active Comparator: morphine
pain relief by administration of morphine
Drug: morphine
Administration of intravenous morphine 0.1 mg/kg
Other Name: morphine as a single drug

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129934

Contact: Ofir Uri, M.D 972-52-4262285 ofiruri@gmail.com

Tel-Aviv Sourasky Medical Center Not yet recruiting
Tel-Aviv, Israel
Contact: Ofir Uri, M.D    972-52-4262285    ofiruri@gmail.com   
Contact: Pinchas Halpern, M.D    972-52-4266681    dr_halperin@tasmc.health.gov.il   
Principal Investigator: Pinchas Halpern, M.D         
Sub-Investigator: Ofir Uri, M.D         
Sub-Investigator: Amir Shapira, M.D         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Study Chair: Pinchas Halpern, M.D Tel-Aviv Medical Center, Tel-Aviv University, Israel

Responsible Party: Dr. Halpern Pinchas, Chair, Department of Emergency Medicine, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01129934     History of Changes
Other Study ID Numbers: TASMC-09-PH-701-CTIL
First Posted: May 25, 2010    Key Record Dates
Last Update Posted: May 25, 2010
Last Verified: May 2010

Keywords provided by Tel-Aviv Sourasky Medical Center:
Low Back Pain,
Emergency medicine,
Pain relief

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Anesthetics, Local