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

Low Back Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Low Back Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Drug:morphineAdministration of intravenous morphine 0.1 mg/kg

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Morphine-PromethazinePain relief by administration of morphine-promethazine combination

morphinepain relief by administration of morphine

Study Status

Unknown status

Start Date: May 2010

Completed Date: January 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Pain relief

Secondary Outcome: Ambulatory status

Study sponsors, principal investigator, and references

Principal Investigator: Pinchas Halpern, M.D

Lead Sponsor: Tel-Aviv Sourasky Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01129934

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