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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Morphine-Promethazine
morphine
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain,, Emergency medicine,, Promethazine,, Morphine,, Pain relief

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tel-Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Morphine-Promethazine

morphine

Arm Description

Pain relief by administration of morphine-promethazine combination

pain relief by administration of morphine

Outcomes

Primary Outcome Measures

Pain relief
Pain scores before and after treatment will be assessed on a 100mm VAS. The difference will be regarded as pain relief.

Secondary Outcome Measures

Ambulatory status
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.

Full Information

First Posted
April 21, 2010
Last Updated
May 23, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01129934
Brief Title
Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department
Official Title
Pharmacological Anxiolysis With Promethazine as an Adjunctive Therapy for Acute Low Back Pain in the Adult Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain,, Emergency medicine,, Promethazine,, Morphine,, Pain relief

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morphine-Promethazine
Arm Type
Experimental
Arm Description
Pain relief by administration of morphine-promethazine combination
Arm Title
morphine
Arm Type
Active Comparator
Arm Description
pain relief by administration of morphine
Intervention Type
Drug
Intervention Name(s)
Morphine-Promethazine
Other Intervention Name(s)
morphine-phenergan
Intervention Description
administration of intravenous morphine 0.1mg/kg and promethazine 12.5 mg in a 500 Ml 0.9% saline
Intervention Type
Drug
Intervention Name(s)
morphine
Other Intervention Name(s)
morphine as a single drug
Intervention Description
Administration of intravenous morphine 0.1 mg/kg
Primary Outcome Measure Information:
Title
Pain relief
Description
Pain scores before and after treatment will be assessed on a 100mm VAS. The difference will be regarded as pain relief.
Time Frame
Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)
Secondary Outcome Measure Information:
Title
Ambulatory status
Description
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.
Time Frame
Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ofir Uri, M.D
Phone
972-52-4262285
Email
ofiruri@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pinchas Halpern, M.D
Organizational Affiliation
Tel-Aviv Medical Center, Tel-Aviv University, Israel
Official's Role
Study Chair
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ofir Uri, M.D
Phone
972-52-4262285
Email
ofiruri@gmail.com
First Name & Middle Initial & Last Name & Degree
Pinchas Halpern, M.D
Phone
972-52-4266681
Email
dr_halperin@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Pinchas Halpern, M.D
First Name & Middle Initial & Last Name & Degree
Ofir Uri, M.D
First Name & Middle Initial & Last Name & Degree
Amir Shapira, M.D

12. IPD Sharing Statement

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

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