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

Low Back Pain Clinical Trial

Official title:

Pharmacological Anxiolysis With Promethazine as an Adjunctive Therapy for Acute Low Back Pain in the Adult Emergency Department

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01129934
• Other study ID #: TASMC-09-PH-701-CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 21, 2010
• Last updated: May 23, 2010
• Start date: May 2010
• Est. completion date: January 2013

Study information

• Verified date: May 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Ofir Uri, M.D
• Phone: 972-52-4262285
• Email: ofiruri[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Emergencies
• Low Back Pain

Intervention

Drug:
• Morphine-Promethazine
administration of intravenous morphine 0.1mg/kg and promethazine 12.5 mg in a 500 Ml 0.9% saline
• morphine
Administration of intravenous morphine 0.1 mg/kg

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	Pain scores before and after treatment will be assessed on a 100mm VAS. The difference will be regarded as pain relief.	Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)	No
Secondary	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.	Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)	No