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

University of Monastir

Status and phase: Completed; Early Phase 1

Conditions: Renal Colic

Treatments: Device: acupuncture; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02152410

48003/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

acupuncture group

Experimental group

Description:

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).

Treatment:

Device: acupuncture

Morphine group

Active Comparator group

Description:

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).

Treatment:

Drug: Morphine