Acupuncture Versus IV Morphine in the Treatment of Acute Pain in ED (AcuMoPE)

Comparison of Two Antalgic Strategies: Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in Emergency Departement. A Randomized Trial of Efficacy and Safety

Renal colics are a common cause af acute intense pain in medical emergency settings requiring often the use of high level antalgics (opioid) to relief the patient.

In the other hand, Acupuncture is well known widely for its therapeutic characteristics, especially in relieving pain.

the aim of these study is to compare this two pain relieving techniques in patients consulting the emergency departement (ED) for acute onset renal colics.

Study Overview

• Status: Completed
• Conditions: Renal Colic
• Intervention / Treatment: Device: acupuncture; Drug: Morphine

Detailed Description

acute onset pain is a frequent cause for consulting the ED (2/3 of patients). renal colics are a common cause for severe acute onset pain, we think approximatively 20% of patients consulting the ED for severe (VAS > 70) acute onset pain have renal colics (RC).

the guidelines for the treatment of severe RC recommend the association of two drugs: a nonsteroidal anti-inflammatory agent (NSAI) typically the Ketoprofen and an antalgic typically opioid (Morphine).

but this one face many critics regarding its safety and tolerance, that's why we investigated other pain relief strategies such as acupuncture.

acupuncture is one of the five branches of the traditional chinese medicine, it has proven its efficacity and safety in many conditions and in RC.

the aim of these study is to assess the feasibility, the safety, and the tolerance of an acupuncture pain-relief strategy compared to the conventional one (intravenous opioids) in the treatment of severe acute onset RC in emergency departement settings.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Fattouma Bourguiba University Hospital
  • Non-US/Canada
    • Monastir, Non-US/Canada, Tunisia, 5000
      • University of Monastir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age over 18 years

  • has a renal colic
  • VAS over 70
  • has not got another analgesic drug before coming to emergency departement

Exclusion Criteria:

• age under 18 years

  • has not renal colic
  • VAS under 70
  • has got another analgesic treatment before coming to emergency departement
  • fever (T° > 38.5°c)
  • cutaneous infection in the punction sites
  • anuric patient
  • contre indication of morphine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture group; The patient receives acupuncture session lasts between 20 to 30 minutes. Acupuncture will be applied according to the standards for reporting interventions in clinical trials of acupuncture (STRICTA).	Device: acupuncture; Acupuncture will be applied according to the standards for reporting interventions in clinical trials of acupuncture (STRICTA)
Active Comparator: Morphine group; Each patient must receive a bolus of 5 mg of morphine (5 cc) and 2 mg (2cc) every 10 minutes if no improvement (VAS> 30).	Drug: Morphine; bolus of 5 mg of morphine (5 cc) and 2 mg (2cc) every 10 minutes if no improvement of VAS (VAS> 30).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain relief by VAS	the primary outcome is to assess the efficacity of acupuncture versus IV morphine expressed in VAS reduction during treatment. if there is a reduction of more than 50% of the baseline VAS, than the treatment is considered efficient.	at baseline, 10, 20, 30, 45 and 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects	during the 60 minutes of the treatment, we checked the patient for side effects: for morphine: rush, nausea, vomiting, dizziness, dyspnea...; for acupuncture: needle fracture, needle retention, muscular contractions... if there are no major side effects noted (vomiting, severe dizziness, allergic reaction, needle fracture) the treatment is considered safe.	during the 60 minutes of the treatment
number of patients completing the treatment	we calculated the number of patients that accepted the acupuncture treatment versus patient with conventional treatment	at baseline

Collaborators and Investigators

• Sponsor: University of Monastir
• Collaborators: Emergency NGO Onlus
• Investigators: Principal Investigator: Nouira Samir, Professor, University Hospital of Monastir

Publications and helpful links

General Publications

• Lee YH, Lee WC, Chen MT, Huang JK, Chung C, Chang LS. Acupuncture in the treatment of renal colic. J Urol. 1992 Jan;147(1):16-8. doi: 10.1016/s0022-5347(17)37121-5.

Helpful Links

• Acupuncture has a good analgesic effect with a low incidence of adverse reactions.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: September 11, 2013
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Estimate): June 20, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: acupuncture; renal colic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Renal Colic; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 48003/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes