Acupuncture Versus Titrated Morphine in Patients With Renal Colic

Study Overview
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Brief Summary
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The aim of this study is to compare the clinical efficacy and safety profiles of a 30 minutes acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous morphine in the management of acute severe pain syndromes (defined as a visual analogue scale (VAS) score >/= 70) taking for example acute renal colic.

Detailed Description
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acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous morphine in the management of acute severe pain syndromes (defined as a visual analogue scale (VAS) score >/= 70) taking for example acute renal colic.

Official Title
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Comparison of Acupuncture and Titrated (TM) Morphine in Patients Presenting to the Emergency Room (ER) With Acute Renal Colic (RC)

Conditions
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Renal Colic

Intervention / Treatment
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* Procedure: Traditional Acupuncture Session
* Drug: Morphine Titration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years old Presenting with acute non complicated renal colic Baseline VAS score >/= 70 Exclusion Criteria: complicated renal colic VAS score < 70 Pain of traumatic origin Coagulation abnormalities Skin affections impairing the use of pre-specified insertion points Enable to use the VAS Patients who received analgesics less than 6 hours prior to enrollment Patients refusing or enable to give written informed consent Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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<br>Traditional Acupuncture Session:Patients in this group will benefit from a 30 minutes acupuncture session made by an experimented physician. | Procedure: Traditional Acupuncture Session<br>* Skin disinfection was made by an antiseptic solution in the sites of insertion and sterile acupuncture needles were used (0.25 x 0.5 mm). Patients were installed in a seated position and needles were inserted perpendicularly through the skin to a depth of 1 - 2 cm until the De Qi was achieved. The DeQi corresponds to a feeling of numbness and tingling within the range of acupoint, The insertion sites are represented by the urinary bladder meridian points to the side of the pain (UB21, UB22, UB23, UB24, UB26, UB45, UB46, UB47, UB48 and UB49).<br>|
| Active Comparator: Titrated Morphine<br>Morphine Titration:Patients will receive an intravenous titration of morphine by a qualified nurse. | Drug: Morphine Titration<br>* Morphine was previously prepared by a study nurse by diluting a 10 mg / 1 ml flakon of morphine chlorhydrate in a 9 ml solution of serum saline to obtain a 10 ml preparation (1 ml = 1 mg). An initial bolus of 0.1 mg per Kg of actual body weight of morphine chlorhydrate solution is administered. A titration dose of 0.1 mg / Kg of body weight was repeated every 5 minutes' interval until reaching the therapeutic goal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score Change | Pain score is measured by a 100 millimeter visual analogue scale (VAS) and corresponds to the severity of the pain felt by the patient and varying from 0 (corresponding to no pain) to 100 (corresponding to the maximum imaginable pain). | at baseline and 10, 20, 30, 45 and 60 minutes after the start of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | Corresponds to the occurence of side effects related to the intervention. Side effects occurence is evaluated via a checklist for each study group and the degree of amputability is evaluated via a 3 point likert scale (1: not probable, 2: probable and 3 : very probable / almost certain). In the morphine group we followed patients for the occurence of drowsiness, dizziness, nausea and vomiting, respiratory distress and hypotension. In the acupuncture group we followed patients for the occurence of local rush / bleeding / itching, needle blockage and fainting | during the 1 hour protocol and up to 2 hours after |