Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department
Recruitment status was Not yet recruiting
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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 |
- 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.
- 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 |
Inclusion Criteria:
- An indication for opioid analgesia based in the ED (i.e. severe pain > 70mm on a 100mm VAS)
- Age between 18-65 years
- American Society of Anesthesiologists (ASA) score of 1 or 2, and no preexisting glaucoma, cardiac arrhythmia or pulmonary disease
- Systolic blood pressure higher than 90 mmHg on admission
- Willingness and ability to provide an informed consent
- No known hypersensitivity to the medication used.
Exclusion Criteria:
- Pregnant women
- Patients who can not be under adult supervision following discharge from the emergency department.
Contacts and Locations| Contact: Ofir Uri, M.D | 972-52-4262285 | ofiruri@gmail.com |
| 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 | |
| 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 Promethazine Diphenhydramine Morphine Antipruritics Dermatologic Agents Therapeutic Uses |
Pharmacologic Actions Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Allergic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Hypnotics and Sedatives Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 22, 2013