Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 21, 2010 | ||||
| Last Updated Date | May 23, 2010 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01129934 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department | ||||
| Official Title ICMJE | Pharmacological Anxiolysis With Promethazine as an Adjunctive Therapy for Acute Low Back Pain in the Adult Emergency Department | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
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| Condition ICMJE | Low Back Pain | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | January 2013 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01129934 | ||||
| Other Study ID Numbers ICMJE | TASMC-09-PH-701-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Halpern Pinchas, Chair, Department of Emergency Medicine, Tel-Aviv Sourasky Medical Center | ||||
| Study Sponsor ICMJE | Tel-Aviv Sourasky Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Tel-Aviv Sourasky Medical Center | ||||
| Verification Date | May 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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