NCT02781415

Acupuncture Versus Titrated Morphine in Patients With Renal Colic

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Monastir · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Renal Colic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-07-01
• Completion: 2016-06-01
• First posted: 2016-05-24
• Last updated: 2016-06-21

Locations

1 site across 1 country: Tunisia