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

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ClinicalTrials.gov Identifier: NCT02152410
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 20, 2016
Sponsor:
Collaborator:
Emergency NGO Onlus
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Renal Colic Device: acupuncture Drug: Morphine Early Phase 1

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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).




Primary Outcome Measures :
  1. pain relief by VAS [ Time Frame: at baseline, 10, 20, 30, 45 and 60 minutes ]

    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.



Secondary Outcome Measures :
  1. side effects [ Time Frame: during the 60 minutes of the treatment ]

    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.

  2. number of patients completing the treatment [ Time Frame: at baseline ]
    we calculated the number of patients that accepted the acupuncture treatment versus patient with conventional treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT02152410


Locations
Tunisia
university of Monastir
Monastir, Non-US/Canada, Tunisia, 5000
Fattouma Bourguiba University Hospital
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Emergency NGO Onlus
Investigators
Principal Investigator: Nouira Samir, Professor University hospital of Monastir

Additional Information:
Publications of Results:
Responsible Party: Pr. Semir Nouira, professor, University of Monastir
ClinicalTrials.gov Identifier: NCT02152410     History of Changes
Other Study ID Numbers: 48003/12
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Pr. Semir Nouira, University of Monastir:
acupuncture
renal colic

Additional relevant MeSH terms:
Acute Pain
Renal Colic
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents