Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients

Phase 4

Completed

• Conditions: Intubation Complication
• Interventions: Drug: Normal saline; Drug: Benzydamine Hydrochloride

• Registration Number: NCT03074968
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2017-02-26
• Study First Submitted QC: 2017-03-04
• Study Start: 2017-03-08
• Study First Posted: 2017-03-09
• Primary Completion: 2018-03-13
• Status Verified: 2018-04
• Study Completion: 2018-04-05
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• general anesthesia
• intubation require

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Exclusion Criteria

• recent upper airway infection
• could not express the pain

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Normal saline	normal saline
benzydamine hydrochloride	Benzydamine Hydrochloride	Benzydamine Hydrochloride

Primary Outcome Measures

Name	Time	Method
pain	30 minutes in postanesthetic care unit	application based pain score

Trial Locations

Locations (1)

SNUH; 🇰🇷 Seoul, Jongro Gu, Korea, Republic of