the Effect of Spray on Propofol Injection Pain

December 5, 2016 updated by: Young Eun Moon, The Catholic University of Korea

the Effect of Ethyl Chloride Spray on Propofol Injection Pain

While propofol is widely used an anesthetic induction medication, it causes the mild to moderate pain. Investigators will investigate the effect of ethyl chloride spray on propofol injection pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seocho-gu
      • Seoul, Seocho-gu, Korea, Republic of, 137-701
        • Youngeun Moon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • the female patients undergoing hysteroscopy

Exclusion Criteria:

  • the patients who are pregnant, have Raynaud's syndrome, or receive the pain killer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: spray
apply the ethyl chloride spray before propofol injection
Drug: ethyl chloride spray
apply the spray for 5 seconds on the dorsal hand before propofol iv injection
Other Names:
  • spray
ACTIVE_COMPARATOR: lidocaine
apply the lidocaine 0.5 mg/kg under the touniquette state before propofol injection
Drug: lidocaine
apply lidocaine under the tourniquet state before propofol iv injection
PLACEBO_COMPARATOR: placebo
apply the saline before propofol injection
Drug: placebo
apply normal saline before propofol iv injection
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
propofol injection pain
Time Frame: right after the propofol injection
Propofol injection pain will be measured using the VAS (Visual analogue scale; 0cm=no pain, 10cm=the worst pain)
right after the propofol injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Youngeun Moon, MD, Assitant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (ESTIMATE)

May 12, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC 2016-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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