Clinical Trials Directory

Trials / Completed

CompletedNCT02460913

Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department

Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department. An Efficacy and Safety Study

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
300 (actual)
Sponsor
University of Monastir · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Inadequate pain management is a common problem encountered in ED settings. Pain relief medications use is often limited by their side effects. Evidence suggests that non pharmacologic pain relief techniques such as acupuncture can play a central role to treat pain in acute conditions, but their application is still scarce.

Detailed description

Pain is a common cause of emergency department visits and its control remains a challenge and health priority worldwide. Many techniques were developed to control pain and to ensure patients comfort but their application is still difficult especially in emergency department (ED) settings, due to the variety of treated conditions, the non-availability of qualified practitioners and the patient's specificity. Pharmacologic methods in particular IV opioids are the most used and with regard to their rapid action with high efficacy. But the use of these drugs can be limited by their side effects. Non-pharmacologic pain relief techniques such as acupuncture have been proposed. During the second half of the twentieth century, acupuncture was established in Europe and in the last two decades, it has spread around the world. In Tunisia, acupuncture was introduced into the health system in the 90s, particularly to treat pain. The World Health Organization (WHO) has recognized acupuncture as safe and sound therapy. A preliminary list of acupuncture indications has been reported including 43 diseases. However, the introduction of acupuncture in the treatment of pain in ED is more recent or even anecdotal. In the treatment of chronic pain, it was shown that acupuncture is comparable to morphine and that its better safety profile makes it the method of choice in some clinical conditions. In a recent systematic review, it has been concluded that there is insufficient evidence for the use of acupuncture in the ED settings due to the paucity of randomized controlled trials and the suboptimal methodological qualities of related studies. The aim of our study was to evaluate the efficacy and safety of acupuncture compared with morphine for the management of acute pain in ED.

Conditions

Interventions

TypeNameDescription
PROCEDUREAcupunctureAcupuncture session of 20 to 30 minutes. Treatment protocols were determined through review of major clinical manuals and textbooks, literature review, and a panel of specialist acupuncturists from Chinese medicine backgrounds.
DRUGMorphine titrationPatients in this group received IV titrated morphine. Morphine was prepared onsite and diluted in a manner to obtain a dose of 1mg in each ml of normal saline. The initial dose was 0.1 mg per kg and a titration dose of 0.05 mg per Kg was repeated every 5 minutes until reaching objective. The maximum allowed dose was 1.5 mg/kg.

Timeline

Start date
2012-04-01
Primary completion
2013-03-01
Completion
2013-03-01
First posted
2015-06-03
Last updated
2020-02-21

Source: ClinicalTrials.gov record NCT02460913. Inclusion in this directory is not an endorsement.