NCT02770690

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_4 pain

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

April 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 7, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

April 26, 2016

Last Update Submit

December 5, 2016

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • propofol injection pain

    Propofol injection pain will be measured using the VAS (Visual analogue scale; 0cm=no pain, 10cm=the worst pain)

    right after the propofol injection

Study Arms (3)

spray

EXPERIMENTAL

apply the ethyl chloride spray before propofol injection

Drug: ethyl chloride spray

lidocaine

ACTIVE COMPARATOR

apply the lidocaine 0.5 mg/kg under the touniquette state before propofol injection

Drug: lidocaine

placebo

PLACEBO COMPARATOR

apply the saline before propofol injection

Drug: placebo

Interventions

ethyl chloride sprayDRUG

apply the spray for 5 seconds on the dorsal hand before propofol iv injection

Also known as: spray
spray
lidocaineDRUG

apply lidocaine under the tourniquet state before propofol iv injection

lidocaine
placeboDRUG

apply normal saline before propofol iv injection

Also known as: normal saline
placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the female patients undergoing hysteroscopy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youngeun Moon

Seoul, Seocho-gu, 137-701, South Korea

Location

MeSH Terms

Conditions

Pain

Interventions

LidocaineSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Youngeun Moon, MD

    Assitant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 26, 2016

First Posted

May 12, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 7, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)