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

Renal Colic Clinical Trial

— AcuMoPE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152410
• Other study ID #: 48003/12
• Status: Completed
• Phase: Phase 0
• First received: September 11, 2013
• Last updated: June 17, 2016
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: June 2016
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Office of Pharmacies and Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Renal Colic

Intervention

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

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

Locations

Country	Name	City	State
Tunisia	Fattouma Bourguiba University Hospital	Monastir
Tunisia	university of Monastir	Monastir	Non-US/Canada

Sponsors (2)

Lead Sponsor	Collaborator
University of Monastir	Emergency NGO Onlus

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	number of patients completing the treatment	we calculated the number of patients that accepted the acupuncture treatment versus patient with conventional treatment	at baseline	No

External Links

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