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

Phase 4

Completed

• Conditions: Electrodiagnosis
• Interventions: Device: vapocoolant spray; Drug: topical anesthetic cream

• Registration Number: NCT01606046
• Lead Sponsor: The Catholic University of Korea

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.

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-08
• Status Verified: 2012-05
• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-25
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vapocoolant spray	vapocoolant spray	-
topical anesthetic agent	topical anesthetic cream	-

Primary Outcome Measures

Name	Time	Method
visual analogue scale, 5 point Likert scale	Immediately after the complete of needle electromyography

Trial Locations

Locations (1)

Soonc chun hyang university hospital Bucheon; 🇰🇷 Bucheon-si, Gyeonngi-do, Korea, Republic of