The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Venous Cannulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Younghoon Jeon, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01607463
First received: May 22, 2012
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

The purpose of this study was to investigate whether transcutaneous electrical nerve stimulation (TENS) could reduce pain during cannulation of vein.


Condition Intervention
Cannulation Pain
Procedure: Transcutaneous electrical nerve stimulation (Empi, USA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Venous Cannulation

Further study details as provided by Kyungpook National University:

Primary Outcome Measures:
  • The effect of transcutaneous electrical nerve stimulation on pain during venous cannulation [ Time Frame: one minute after cannulation ] [ Designated as safety issue: No ]
    One hundred patients were allocated randomly to two groups: In the active TENS group TENS was delivered via two electrodes on the venous cannulation site (radial side of the wrist of dominant forearm) 20 min prior to venous cannulation and control group received placebo (no current) TENS. Venous cannulation with a 22 gage cannula was performed. One minute after venous cannulation the pain intensity (0 = no pain, 10 = worst pain imaginable) was measured. Any side effects during study periods were recorded


Enrollment: 100
Study Start Date: May 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active TENS group
Two electrodes were attached to the radial side of dominant forearm. In the active TENS group, TENS was delivered via two electrodes on the venous cannulation site
Procedure: Transcutaneous electrical nerve stimulation (Empi, USA)
In the active TENS group, TENS at 80 pulsed currents per second (PPS) with a pulse duration of 200 μs were delivered for 20 minutes. Current amplitude was slowly increased until a level was reached that participants reported was the maximum level they could tolerate below pain threshold without noticeable muscle contraction and maintained this intensity.
Placebo Comparator: Placebo group
Two electrodes were attached to the radial side of dominant forearm. In the placebo group the TENS device had no current output although the power "on" indicator light remained active.
Procedure: Transcutaneous electrical nerve stimulation (Empi, USA)
In the placebo group the TENS device had no current output although the power "on" indicator light remained active.

Detailed Description:

One hundred patients were allocated randomly to two groups: In the active TENS group TENS was delivered via two electrodes on the venous cannulation site (radial side of the wrist of dominant forearm) 20 min prior to venous cannulation and control group received placebo (no current) TENS. Venous cannulation with a 22 gage cannula was performed. During venous cannulation the pain intensity (0 = no pain, 10 = worst pain imaginable) was measured. Any side effects during study periods were recorded

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • outpatients who underwent plastic surgery

Exclusion Criteria:

  • concomitant sedative or analgesic medication,
  • neurological disease.
  • all patients with potentially dangerous internal diseases (American Society of Anesthesiologists' physical status > 3).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607463

Sponsors and Collaborators
Kyungpook National University
Investigators
Principal Investigator: Younghoon Jeon, Dr 2. Anesthesiology and Pain Medicine, Kyungpook National University Hospital
  More Information

No publications provided

Responsible Party: Younghoon Jeon, Anesthesiology and Pain Medicine, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01607463     History of Changes
Other Study ID Numbers: KNUH 2012-04-014-001
Study First Received: May 22, 2012
Last Updated: May 24, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Kyungpook National University:
pain
transcutaneous electrical nerve stimulation

ClinicalTrials.gov processed this record on April 15, 2014