Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department (AcuMAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02460913|
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : February 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Procedure: Acupuncture Drug: Morphine titration||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department. An Efficacy and Safety Study|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
patients received a 20 to 30 minutes session of acupuncture
Acupuncture 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.
Active Comparator: IV Morphine
patients received an intravenous titration of morphine every 5 minutes.
Drug: Morphine titration
Patients 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.
Other Name: Morphine
- change of pain severity from baseline [ Time Frame: 10, 20, 30, 45, 60 minutes ]
Change of pain score was assessed at 10, 20, 30, 45 and 60 minutes time points from the starting of the protocol.
Pain severity was measured using the visual analogic scale (VAS) going from 10 (maximum imaginable pain) to 0 (no pain). if the VAS was not applicable to certain patients, a verbal numeric rating scale (NRS) was used instead.
Success of treatment was defined by a drop in the pain intensity under 30.
- resolution time [ Time Frame: 10, 20, 30, 45, 60 minutes ]This interval was defined by the time (in minutes) elapsed between the start of the protocol (T0) and the decrease of the pain score of at least 50% of its initial value.
- adverse events [ Time Frame: 10, 20, 30, 45, 60 minutes and until ED discharge ]
Occurrence of major side effects implicates the immediate ending of the protocol, more particularly:
- Allergic manifestations such as rush and generalized edema
- severe hypotension defined by a drop of the systolic blood pressure under 90 mmHg or a loss of more than 20 mmHg of the initial systolic blood pressure
- recurrent vomiting non controlled by the standard measures
- Altered mental status
- Uncontrolled bleeding from the site of needle insertion
- Respiratory distress with capillary saturation under 95% or signs of pneumothorax
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460913
|Principal Investigator:||nouira semir, MD||University of Monastir|