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

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ClinicalTrials.gov Identifier: NCT01607463
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : May 30, 2012
Sponsor:
Information provided by (Responsible Party):
Younghoon Jeon, Kyungpook National University

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

Condition or disease Intervention/treatment Phase
Cannulation Pain Procedure: Transcutaneous electrical nerve stimulation (Empi, USA) Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Venous Cannulation
Study Start Date : May 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. The effect of transcutaneous electrical nerve stimulation on pain during venous cannulation [ Time Frame: one minute after cannulation ]
    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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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).

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): NCT01607463


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012

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