Acupuncture Versus Titrated Morphine in Patients With Renal Colic (AcuRC)
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|ClinicalTrials.gov Identifier: NCT02781415|
Recruitment Status : Completed
First Posted : May 24, 2016
Last Update Posted : June 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Renal Colic||Procedure: Traditional Acupuncture Session Drug: Morphine Titration||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Acupuncture and Titrated (TM) Morphine in Patients Presenting to the Emergency Room (ER) With Acute Renal Colic (RC)|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||June 2016|
Traditional Acupuncture Session:Patients in this group will benefit from a 30 minutes acupuncture session made by an experimented physician.
Procedure: Traditional Acupuncture Session
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).
Active Comparator: Titrated Morphine
Morphine Titration:Patients will receive an intravenous titration of morphine by a qualified nurse.
Drug: Morphine Titration
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.
- Pain score Change [ Time Frame: at baseline and 10, 20, 30, 45 and 60 minutes after the start of intervention ]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).
- Number of participants with treatment-related adverse events [ Time Frame: during the 1 hour protocol and up to 2 hours after ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781415
|Fattouma Bourguiba University Hospital|
|Monastir, Tunisia, 5000|
|Principal Investigator:||Nouira Semir, Professor||University Hospital of Monastir|