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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Young Eun Moon, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01606046
First received: May 23, 2012
Last updated: June 19, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Electrodiagnosis
Device: vapocoolant spray
Drug: topical anesthetic cream
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Needle Electromyography: a Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • visual analogue scale, 5 point Likert scale [ Time Frame: Immediately after the complete of needle electromyography ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: July 2011
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vapocoolant spray Device: vapocoolant spray
spray for 5 seconds from a distance of 30 cm just before the needle EMG
Other Name: 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 Name: EMLA® (Eutectic Mixture of Local Anesthetics)
No Intervention: Control
no interventions

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.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606046

Locations
Korea, Republic of
Soonc chun hyang university hospital Bucheon
Bucheon-si, Gyeonngi-do, Korea, Republic of, 420-767
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: SangHyun Kim, Professor Department of rehabilitation, Soon chun hyang university hospital Bucheon
  More Information

No publications provided

Responsible Party: Young Eun Moon, Clinical Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01606046     History of Changes
Other Study ID Numbers: momo0910
Study First Received: May 23, 2012
Last Updated: June 19, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Anesthetics, Local
Ethyl Chloride
EMLA
Lidocaine
Prilocaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Combined
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014