Clinical Trial: Acupuncture Versus Titrated Morphine in Patients With Renal Colic

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: University of Monastir

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: 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



Original Secondary Outcome: Same as current

Information By: University of Monastir

Dates:
Date Received: May 16, 2016
Date Started: July 2014
Date Completion:
Last Updated: June 18, 2016
Last Verified: June 2016