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Clinical Trials/NCT01606046
NCT01606046
Completed
Phase 4

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

The Catholic University of Korea1 site in 1 country99 target enrollmentJuly 2011

Overview

Phase
Phase 4
Intervention
vapocoolant spray
Conditions
Electrodiagnosis
Sponsor
The Catholic University of Korea
Enrollment
99
Locations
1
Primary Endpoint
visual analogue scale, 5 point Likert scale
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
August 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Young Eun Moon

Clinical Professor

The Catholic University of Korea

Eligibility Criteria

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

Arms & Interventions

vapocoolant spray

Intervention: vapocoolant spray

topical anesthetic agent

Intervention: topical anesthetic cream

Outcomes

Primary Outcomes

visual analogue scale, 5 point Likert scale

Time Frame: Immediately after the complete of needle electromyography

Study Sites (1)

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