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

Study Overview
=================
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.

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

Conditions
-----------------
Renal Colic

Intervention / Treatment
-----------------
* Device: acupuncture
* Drug: Morphine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture group<br>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<br>* Acupuncture will be applied according to the standards for reporting interventions in clinical trials of acupuncture (STRICTA)<br>|
| Active Comparator: Morphine group<br>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<br>* bolus of 5 mg of morphine (5 cc) and 2 mg (2cc) every 10 minutes if no improvement of VAS (VAS> 30).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| number of patients completing the treatment | we calculated the number of patients that accepted the acupuncture treatment versus patient with conventional treatment | at baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, renal colic