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

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ClinicalTrials.gov Identifier: NCT02460913
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : June 9, 2015
Sponsor:
Information provided by (Responsible Party):
Nouira, University of Monastir

Tracking Information
First Submitted Date  ICMJE May 25, 2015
First Posted Date  ICMJE June 3, 2015
Last Update Posted Date June 9, 2015
Study Start Date  ICMJE April 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2015)
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 of at least 50% of its baseline value (T0).
Change History Complete list of historical versions of study NCT02460913 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2015)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE
  • Procedure: 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Acupuncture
    patients received a 20 to 30 minutes session of acupuncture
    Intervention: Procedure: Acupuncture
  • Active Comparator: IV Morphine
    patients received an intravenous titration of morphine every 5 minutes.
    Intervention: Drug: Morphine titration
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2015)
300
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute onset pain < 72 hours of the ED presentation
  • Pain intensity ≥ 40 of the VAS or NRS (ranging from 0 for no pain to 100 for maximum imaginable pain)
  • Acute musculoskeletal pain with no evidence of fracture or dislocation, including ankle and knee sprains without signs of severity (ligament rupture, laxity), shoulder and elbow tendinitis, upper and lower limb mechanical pains and lower back pain with no evidence of neurological deficit.
  • Acute abdominal pain with no urging surgical intervention including renal colic and dysmenorrhea.
  • Acute headache that meets the criteria of primary headache, as described by the international headache society.

Exclusion Criteria:

  • Temperature > 37.7°c
  • Violent mechanism of trauma
  • Patients under anticoagulant drugs or with coagulation abnormalities
  • Skin affections (infections, hematoma, dermatosis) that would impair the use of certain acupuncture points
  • Patients that were judged enable to participate in the study at the discretion of the treating physician.
  • Refusal, inability to consent.
  • Inability to assess the degree of pain using the VAS or NRS
  • Patients who had received analgesics in the 6 hours prior to the enrollment
  • An initial pain score ≤ 40 on the VAS or NRS
  • Patients who had presented to the ED in the last 24 hours with the same motif
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02460913
Other Study ID Numbers  ICMJE 13/02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nouira, University of Monastir
Study Sponsor  ICMJE University of Monastir
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Monastir
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP