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Completed

NCT Number: NCT02152410

Acupuncture Versus IV Morphine in the Treatment of Acute Pain in ED

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.

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Key information

Conditions

Renal Colic Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Fattouma Bourguiba University Hospital, Monastir, Monastir Governorate, Tunisia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

Device

Acupuncture will be applied according to the standards for reporting interventions in clinical trials of acupuncture (STRICTA)

Morphine

Drug

bolus of 5 mg of morphine (5 cc) and 2 mg (2cc) every 10 minutes if no improvement of VAS (VAS> 30).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Collaborators

  • Emergency NGO Onlus

Registry information

Official study 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

Acronym: AcuMoPE

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 2, 2014
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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