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

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

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.

Study Overview

• Status: Completed
• Conditions: Electrodiagnosis
• Intervention / Treatment: Device: vapocoolant spray; Drug: topical anesthetic cream

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonngi-do
    • Bucheon-si, Gyeonngi-do, Korea, Republic of, 420-767
      • Soonc chun hyang university hospital Bucheon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: vapocoolant spray	Device: vapocoolant spray; spray for 5 seconds from a distance of 30 cm just before the needle EMG; Other Names: Ethyl chloride spray
Active Comparator: topical anesthetic agent	Drug: topical anesthetic cream; application of EMLA cream on the needle electrode insertion site 60 minutes before the needle EMG; Other Names: EMLA® (Eutectic Mixture of Local Anesthetics)
No Intervention: Control; no interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
visual analogue scale, 5 point Likert scale	Immediately after the complete of needle electromyography

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Principal Investigator: SangHyun Kim, Professor, Department of rehabilitation, Soon chun hyang university hospital Bucheon

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: May 23, 2012
• First Submitted That Met QC Criteria: May 24, 2012
• First Posted (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Estimate): June 21, 2012
• Last Update Submitted That Met QC Criteria: June 19, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Combined; Anesthetics; Anesthetics, Local; Lidocaine, Prilocaine Drug Combination; Ethyl Chloride
• Other Study ID Numbers: momo0910