Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department
Recruitment status was Not yet recruiting
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.
|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.
|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)|
Pain relief by administration of morphine-promethazine combination
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
Administration of intravenous morphine 0.1 mg/kg
Other Name: morphine as a single drug
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129934
|Contact: Ofir Uri, M.Dfirstname.lastname@example.org|
|Tel-Aviv Sourasky Medical Center||Not yet recruiting|
|Contact: Ofir Uri, M.D 972-52-4262285 email@example.com|
|Contact: Pinchas Halpern, M.D 972-52-4266681 firstname.lastname@example.org|
|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|