NCT01606046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
Last Updated

June 21, 2012

Status Verified

May 1, 2012

Enrollment Period

Same day

First QC Date

May 23, 2012

Last Update Submit

June 19, 2012

Conditions

Electrodiagnosis

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale, 5 point Likert scale

    Immediately after the complete of needle electromyography

Study Arms (3)

vapocoolant spray

ACTIVE COMPARATOR
Device: vapocoolant spray

topical anesthetic agent

ACTIVE COMPARATOR
Drug: topical anesthetic cream

Control

NO INTERVENTION

no interventions

Interventions

vapocoolant sprayDEVICE

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

Also known as: Ethyl chloride spray
vapocoolant spray
topical anesthetic creamDRUG

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

Also known as: EMLA® (Eutectic Mixture of Local Anesthetics)
topical anesthetic agent

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soonc chun hyang university hospital Bucheon

Bucheon-si, Gyeonngi-do, 420-767, South Korea

Location

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

LidocaineAcetanilidesAnilidesAmidesOrganic ChemicalsPrilocaineAniline CompoundsAminesDrug CombinationsPharmaceutical Preparations

Study Officials

  • SangHyun Kim, Professor

    Department of rehabilitation, Soon chun hyang university hospital Bucheon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 25, 2012

Study Start

July 1, 2011

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

June 21, 2012

Record last verified: 2012-05

Locations

KR(1)