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Completed

NCT Number: NCT01606046

Comparison of the Effects of Vapocoolant Spray and EMLA Cream on Pain During Needle Electromyography

The purpose of this study is to compare the effects of vapocoolant spray and topical lidocaine 2.5% + prilocaine 2.5% cream (EMLA) on reducing pain during needle electromyography.

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Key information

Conditions

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soonc chun hyang university hospital Bucheon

Bucheon-si, Gyeonngi-do, 420-767, South Korea

About this study

The study was conducted on patients with patients that underwent needle EMGs in the lower extremity between July and August 2011 at the university hospital. The patients were divided into a total of three groups by random assignment: a control group that did not receive pretreatment, a group that received ethyl chloride vapocoolant spray and a group that received topical anesthetic cream (EMLA cream®).The patients with spray group, they were sprayed with ethyl chloride vapocoolant spray for 5 seconds from a distance of 30 cm just before the needle EMG, and patients with EMLA cream, they received an application of topical anesthetic cream on the needle electrode insertion site 60 minutes before the needle EMG. The 37-mm monopolar needle electrode was vertically inserted into the medial head of the gastrocnemius muscle in all patients.

To assess the degree of pain for each group, patients were asked to indicate their level of pain on a 100 mm VAS (0, no pain; 100, worst intolerable pain) after the needle EMG in the gastrocnemius muscle.

In both experimental groups, a 5-point Likert scale was used to evaluate patient satisfaction with the pain reduction method used and their willingness to use the same analgesic method in another EMG.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who had a normal schedule of needle EMGs in the lower extremity.

Exclusion criteria

  • those who refused to participate in the experiment
  • those who were unable to understand a VAS and Likert scale
  • those with a history of allergic reaction to vapocoolant spray or lidocaine
  • those with a history of cold intolerance (Raynaud's syndrome, etc.)
  • those who took oral pain medications or used topical anesthetics within 24 hours of the experiment
  • those who exhibited abnormal lower extremity sensation during the physical examination or who showed pain on gastrocnemius

Treatment and study plan

Vapocoolant spray

Device

spray for 5 seconds from a distance of 30 cm just before the needle EMG

Other names: Ethyl chloride spray

Topical Anesthetic Cream

Drug

application of EMLA cream on the needle electrode insertion site 60 minutes before the needle EMG

Other names: EMLA® (Eutectic Mixture of Local Anesthetics)

Primary outcomes

  1. visual analogue scale, 5 point Likert scale

    Time frame: Immediately after the complete of needle electromyography

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Needle Electromyography: a Randomized Controlled Clinical Trial

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 25, 2012
Registry last updated
Jun 21, 2012

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.