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Clinical Trials/NCT01607463
NCT01607463CompletedNot Applicable

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

Kyungpook National University Hospital0 sites100 target enrollmentStarted: May 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Primary Endpoint
The effect of transcutaneous electrical nerve stimulation on pain during venous cannulation

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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).

Arms & Interventions

active TENS group

Experimental

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

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

Placebo group

Placebo Comparator

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.

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Younghoon Jeon

Anesthesiology and Pain Medicine

Kyungpook National University Hospital

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