Clinical trial NCT02152410: Acupuncture Versus IV Morphine in the Treatment of Acute Pain in ED
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Renal Colic
Keywords: acupuncture
renal colic
Lead sponsor: University of Monastir
Sponsor class: OTHER
Collaborators: name: Emergency NGO Onlus
First posted: 2014-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: pain relief by VAS
timeFrame: at baseline, 10, 20, 30, 45 and 60 minutes
Secondary outcomes:
measure: side effects
timeFrame: during the 60 minutes of the treatment
measure: number of patients completing the treatment
timeFrame: at baseline
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: university of Monastir
state: Non-US/Canada
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University Hospital
Study officials:
affiliation: University hospital of Monastir
name: Nouira Samir, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.