NCT03074968

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

February 26, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

March 8, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2018

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

February 26, 2017

Last Update Submit

April 9, 2018

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (1)

  • pain

    application based pain score

    30 minutes in postanesthetic care unit

Study Arms (2)

control

PLACEBO COMPARATOR

normal saline

Drug: Normal saline

benzydamine hydrochloride

ACTIVE COMPARATOR

Benzydamine Hydrochloride

Drug: Benzydamine Hydrochloride

Interventions

Benzydamine HydrochlorideDRUG

Benzydamine Hydrochloride application

Also known as: difflam
benzydamine hydrochloride
Normal salineDRUG

normal saline application

Also known as: ns
control

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • general anesthesia
  • intubation require

You may not qualify if:

  • recent upper airway infection
  • could not express the pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, Jongro Gu, 15710, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32247315DERIVED

MeSH Terms

Interventions

BenzydamineSaline Solution

Intervention Hierarchy (Ancestors)

IndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Hee-Soo Kim

    Seoul National University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 26, 2017

First Posted

March 9, 2017

Study Start

March 8, 2017

Primary Completion

March 13, 2018

Study Completion

April 5, 2018

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

KR(1)