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