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Acupuncture Versus Titrated Morphine in Patients With Renal Colic (AcuRC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781415
First Posted: May 24, 2016
Last Update Posted: June 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir
  Purpose
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.

Condition Intervention Phase
Renal Colic Procedure: Traditional Acupuncture Session Drug: Morphine Titration Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Acupuncture and Titrated (TM) Morphine in Patients Presenting to the Emergency Room (ER) With Acute Renal Colic (RC)

Resource links provided by NLM:


Further study details as provided by Pr. Semir Nouira, University of Monastir:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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



Enrollment: 200
Study Start Date: July 2014
Study Completion Date: June 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
Traditional Acupuncture Session:Patients in this group will benefit from a 30 minutes acupuncture session made by an experimented physician.
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).

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


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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781415


Locations
Tunisia
Fattouma Bourguiba University Hospital
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Investigators
Principal Investigator: Nouira Semir, Professor University Hospital of Monastir
  More Information

Responsible Party: Pr. Semir Nouira, Clinical Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT02781415     History of Changes
Other Study ID Numbers: 14/25
First Submitted: May 16, 2016
First Posted: May 24, 2016
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Colic
Renal Colic
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents