Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients

NCT ID: NCT03074968

Last Updated: 2018-04-11

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

PHASE4

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2018-04-05

Brief Summary

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This study is designed to examine the effect of benzydamine hydrochloride to postoperative sore throat in pediatric patients. We will spray benzydmaine hydrochloride or normal saline at oral cavity and the tip of endotracheal tube, than compare the prevalence of postoperative sore throat using smartphone application in pediatric patients.

Detailed Description

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1. postoperative sore throat incidence (over 2) 1; no, 2;mild, 3;moderate, 4;severe
2. scoring of pain with smartphone application (kids pain scale)
3. incidence of use of rescue pain killer

Conditions

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Intubation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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control

normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

normal saline application

benzydamine hydrochloride

Benzydamine Hydrochloride

Group Type ACTIVE_COMPARATOR

Benzydamine Hydrochloride

Intervention Type DRUG

Benzydamine Hydrochloride application

Interventions

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Benzydamine Hydrochloride

Benzydamine Hydrochloride application

Intervention Type DRUG

Normal saline

normal saline application

Intervention Type DRUG

Other Intervention Names

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difflam ns

Eligibility Criteria

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Inclusion Criteria

* general anesthesia
* intubation require

Exclusion Criteria

* recent upper airway infection
* could not express the pain
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee-Soo Kim

Role: PRINCIPAL_INVESTIGATOR

Seoul National University

Locations

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SNUH

Seoul, Jongro Gu, South Korea

Site Status

Countries

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South Korea

References

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Yhim HB, Yoon SH, Jang YE, Lee JH, Kim EH, Kim JT, Kim HS. Effects of benzydamine hydrochloride on postoperative sore throat after extubation in children: a randomized controlled trial. BMC Anesthesiol. 2020 Apr 4;20(1):77. doi: 10.1186/s12871-020-00995-y.

Reference Type DERIVED
PMID: 32247315 (View on PubMed)

Other Identifiers

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H1612-061-813

Identifier Type: -

Identifier Source: org_study_id

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