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

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ClinicalTrials.gov Identifier: NCT01606046
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : June 21, 2012
Sponsor:
Information provided by (Responsible Party):
Young Eun Moon, 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.

Condition or disease Intervention/treatment Phase
Electrodiagnosis Device: vapocoolant spray Drug: topical anesthetic cream Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : July 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

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 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



Primary Outcome Measures :
  1. visual analogue scale, 5 point Likert scale [ Time Frame: Immediately after the complete of needle electromyography ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606046


Locations
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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
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Principal Investigator: SangHyun Kim, Professor Department of rehabilitation, Soon chun hyang university hospital Bucheon
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Responsible Party: Young Eun Moon, Clinical Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01606046    
Other Study ID Numbers: momo0910
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Anesthetics
Ethyl Chloride
Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Combined