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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01129934
First received: April 21, 2010
Last updated: May 23, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Low Back Pain
Drug: Morphine-Promethazine
Drug: morphine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Pharmacological Anxiolysis With Promethazine as an Adjunctive Therapy for Acute Low Back Pain in the Adult Emergency Department

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Pain relief [ Time Frame: Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital) ] [ Designated as safety issue: No ]
    Pain scores before and after treatment will be assessed on a 100mm VAS. The difference will be regarded as pain relief.


Secondary Outcome Measures:
  • Ambulatory status [ Time Frame: Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129934

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

Locations
Israel
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
Investigators
Study Chair: Pinchas Halpern, M.D Tel-Aviv Medical Center, Tel-Aviv University, Israel
  More Information

No publications provided

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
Study First Received: April 21, 2010
Last Updated: May 23, 2010
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Back Pain
Emergencies
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes
Morphine
Diphenhydramine
Promethazine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 18, 2014