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NCT Number: NCT02781415

Acupuncture Versus Titrated Morphine in Patients With Renal Colic

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.

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Key information

Conditions

Renal Colic Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fattouma Bourguiba University Hospital

Monastir, Monastir Governorate, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Acronym: AcuRC

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 24, 2016
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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