MedDataX Logo

the Effect of Spray on Propofol Injection Pain

NCT ID: NCT02770690

Last Updated: 2016-12-07

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

spray

apply the ethyl chloride spray before propofol injection

Group Type EXPERIMENTAL

ethyl chloride spray

Intervention Type DRUG

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

lidocaine

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

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

apply lidocaine under the tourniquet state before propofol iv injection

placebo

apply the saline before propofol injection

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

apply normal saline before propofol iv injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ethyl chloride spray

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

Intervention Type DRUG

lidocaine

apply lidocaine under the tourniquet state before propofol iv injection

Intervention Type DRUG

placebo

apply normal saline before propofol iv injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

spray normal saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* the female patients undergoing hysteroscopy

Exclusion Criteria

* the patients who are pregnant, have Raynaud's syndrome, or receive the pain killer
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Young Eun Moon

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Youngeun Moon, MD

Role: PRINCIPAL_INVESTIGATOR

Assitant Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Youngeun Moon

Seoul, Seocho-gu, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CMC 2016-1

Identifier Type: -

Identifier Source: org_study_id