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

Information source: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Low Back Pain

Intervention: Morphine-Promethazine (Drug); morphine (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Tel-Aviv Sourasky Medical Center

Official(s) and/or principal investigator(s):
Pinchas Halpern, M.D, Study Chair, Affiliation: Tel-Aviv Medical Center, Tel-Aviv University, Israel

Overall contact:
Ofir Uri, M.D, Phone: 972-52-4262285, Email: ofiruri@gmail.com


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Pain relief

Secondary outcome: Ambulatory status

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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.

Locations and Contacts

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

Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel; Not yet recruiting
Ofir Uri, M.D, Phone: 972-52-4262285, Email: ofiruri@gmail.com
Pinchas Halpern, M.D, Phone: 972-52-4266681, Email: dr_halperin@tasmc.health.gov.il
Pinchas Halpern, M.D, Principal Investigator
Ofir Uri, M.D, Sub-Investigator
Amir Shapira, M.D, Sub-Investigator
Additional Information

Starting date: May 2010
Last updated: May 23, 2010

Page last updated: August 23, 2015

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