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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: University of Monastir

Current Primary Outcome: change of pain severity from baseline [ Time Frame: 10, 20, 30, 45, 60 minutes ]

Original Primary Outcome: change of pain severity from baseline [ Time Frame: 10, 20, 30, 45, 60 minutes ]

Current Secondary Outcome:

• 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

Original Secondary Outcome: Same as current

Information By: University of Monastir

Dates:
Date Received: May 25, 2015
Date Started: April 2012
Date Completion:
Last Updated: June 6, 2015
Last Verified: May 2015