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

April 21, 2010
May 23, 2010
May 2010
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01129934 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Low Back Pain
  • 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
  • Drug: morphine
    Administration of intravenous morphine 0.1 mg/kg
    Other Name: morphine as a single drug
  • Experimental: Morphine-Promethazine
    Pain relief by administration of morphine-promethazine combination
    Intervention: Drug: Morphine-Promethazine
  • Active Comparator: morphine
    pain relief by administration of morphine
    Intervention: Drug: morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
January 2013
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Ofir Uri, M.D 972-52-4262285 ofiruri@gmail.com
Israel
 
NCT01129934
TASMC-09-PH-701-CTIL
No
Dr. Halpern Pinchas, Chair, Department of Emergency Medicine, Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Study Chair: Pinchas Halpern, M.D Tel-Aviv Medical Center, Tel-Aviv University, Israel
Tel-Aviv Sourasky Medical Center
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP