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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Electrodiagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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vapocoolant spray

Group Type ACTIVE_COMPARATOR

vapocoolant spray

Intervention Type DEVICE

spray for 5 seconds from a distance of 30 cm just before the needle EMG

topical anesthetic agent

Group Type ACTIVE_COMPARATOR

topical anesthetic cream

Intervention Type DRUG

application of EMLA cream on the needle electrode insertion site 60 minutes before the needle EMG

Control

no interventions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vapocoolant spray

spray for 5 seconds from a distance of 30 cm just before the needle EMG

Intervention Type DEVICE

topical anesthetic cream

application of EMLA cream on the needle electrode insertion site 60 minutes before the needle EMG

Intervention Type DRUG

Other Intervention Names

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Ethyl chloride spray EMLA® (Eutectic Mixture of Local Anesthetics)

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No