Acupuncture Versus Titrated Morphine in Patients With Renal Colic

Phase 3

Completed

• Conditions: Renal Colic
• Interventions: Procedure: Traditional Acupuncture Session; Drug: Morphine Titration

• Registration Number: NCT02781415
• Lead Sponsor: University of Monastir

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 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.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-07
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-21
• Study First Posted: 2016-05-24
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-18
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Traditional Acupuncture Session	Traditional Acupuncture Session:Patients in this group will benefit from a 30 minutes acupuncture session made by an experimented physician.
Titrated Morphine	Morphine Titration	Morphine Titration:Patients will receive an intravenous titration of morphine by a qualified nurse.

Primary Outcome Measures

Name	Time	Method
Pain score Change	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).

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	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

Trial Locations

Locations (1)

Fattouma Bourguiba University Hospital; 🇹🇳 Monastir, Tunisia