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

NCT ID: NCT01607463

Last Updated: 2012-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-05-31

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

Conditions

Cannulation Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Transcutaneous electrical nerve stimulation (Empi, USA)

Intervention Type: PROCEDURE

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 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.

Group Type: PLACEBO_COMPARATOR

Transcutaneous electrical nerve stimulation (Empi, USA)

Intervention Type: PROCEDURE

In the placebo group the TENS device had no current output although the power "on" indicator light remained active.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyungpook National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Younghoon Jeon

Anesthesiology and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Younghoon Jeon, Dr

Role: PRINCIPAL_INVESTIGATOR

2. Anesthesiology and Pain Medicine, Kyungpook National University Hospital

References

Kim S, Park K, Son B, Jeon Y. The effect of transcutaneous electrical nerve stimulation on pain during venous cannulation. Curr Ther Res Clin Exp. 2012 Sep;73(4-5):134-9. doi: 10.1016/j.curtheres.2012.05.001.

Reference Type: DERIVED

PMID: 24653515 (View on PubMed)

Other Identifiers

KNUH 2012-04-014-001

Identifier Type: -

Identifier Source: org_study_id