A Phase 3 interventional study of Traditional Acupuncture Session and Morphine Titration in Renal Colic, sponsored by University of Monastir. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-21.
Sponsored by University of Monastir · Phase 3, Interventional, and Treatment
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.
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.
81 studies on the registry are indexed under Renal Colic; 10 are open to participants now.
This study's enrollment of 200 is above the median of 111 across 61 interventional studies indexed under Renal Colic.
Browse Renal Colic studies →University of Monastir is the lead sponsor of 114 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Traditional Acupuncture Session:Patients in this group will benefit from a 30 minutes acupuncture session made by an experimented physician.
Procedure: Traditional Acupuncture Session
Morphine Titration:Patients will receive an intravenous titration of morphine by a qualified nurse.
Drug: Morphine Titration
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).
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
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).
Time frame: at baseline and 10, 20, 30, 45 and 60 minutes after the start of intervention
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
Time frame: during the 1 hour protocol and up to 2 hours after
Plan to share: Yes
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The record gives a start of Jul 2014, a primary completion of Jul 2015 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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