Acupuncture Versus Titrated Morphine in Patients With Renal Colic

Renal Colic Clinical Trial

— AcuRC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781415
• Other study ID #: 14/25
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2016
• Last updated: June 18, 2016
• Start date: July 2014
• Est. completion date: June 2016

Study information

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

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colic
• Renal Colic

Intervention

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).

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.

Locations

Country	Name	City	State
Tunisia	Fattouma Bourguiba University Hospital	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No