The Effect of Pregabalin on Pain of Propofol Injection

NCT ID: NCT02668094

Last Updated: 2016-05-11

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

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-03-31

Brief Summary

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Pain is a common side effect of propofol injection. The purpose of this study was to compare the efficacy of pregabalin and lidocaine in reducing propofol injection pain.

Detailed Description

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In a randomized, double blind, prospective trial, 120 patients were allocated to one of three groups (each n=40) receiving intravenous lidocaine 40mg (group L), oral pregabalin 75 mg (group LP), and oral pregabalin 150 mg (group HP) as pretreatment, followed by injection of 25% of 2 mg/kg propofol. Pain was assessed by a four point scale (0=no, 1=mild, 2=moderate, 3=severe pain).

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group L

Lidocaine 40mg was given intravenously before injection of propofol

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

propofol

Intervention Type DRUG

Group LP

Pregabalin 75 mg was given orally 2 hour before surgery

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

propofol

Intervention Type DRUG

Group HP

Pregabalin 150 mg was given orally 2 hour before surgery

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

propofol

Intervention Type DRUG

Interventions

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Lidocaine

Intervention Type DRUG

Pregabalin

Intervention Type DRUG

propofol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient underwent elective dental surgery.

Exclusion Criteria

* Patient with a history of adverse response to lidocaine or pregabalin,
* Patient with cardiovascular or respiratory disease,
* Patient who takes any sedatives, analgesics, or anticonvulsants within 24 hours before surgery.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Younghoon Jeon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Younghoon Jeon, Dr

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National Hosptial

Locations

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Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2015-03-037-001

Identifier Type: -

Identifier Source: org_study_id

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