Acupuncture Versus Titrated Morphine in Patients With Renal Colic

NCT02781415 | Completed Phase 3 DMC

• 1 other identifier: 14/25
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Colic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events

  during the 1 hour protocol and up to 2 hours after

Study Arms (2)

Acupuncture

EXPERIMENTAL

Traditional Acupuncture Session:Patients in this group will benefit from a 30 minutes acupuncture session made by an experimented physician.

Procedure: Traditional Acupuncture Session

Titrated Morphine

ACTIVE COMPARATOR

Morphine Titration:Patients will receive an intravenous titration of morphine by a qualified nurse.

Drug: Morphine Titration

Interventions

Traditional Acupuncture Session PROCEDURE

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).

Acupuncture

Morphine Titration DRUG

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.

Titrated Morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years old
• Presenting with acute non complicated renal colic
• Baseline VAS score \>/= 70

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Fattouma Bourguiba University Hospital

Monastir, Monastir Governorate, 5000, Tunisia

Location

MeSH Terms

Conditions

Renal Colic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nouira Semir, Professor

  University Hospital of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 24, 2016
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: June 1, 2016
• Last Updated: June 21, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)