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NCT03074968 Clinical Trial

Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients

Intubation Complication Clinical Trial

Official title:
Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03074968
Other study ID # H1612-061-813
Secondary ID
Status Completed
Phase Phase 4
First received February 26, 2017
Last updated April 9, 2018
Start date March 8, 2017
Est. completion date April 5, 2018

Study information
Verified date April 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 142
Est. completion date April 5, 2018
Est. primary completion date March 13, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria:

- general anesthesia

- intubation require

Exclusion Criteria:

- recent upper airway infection

- could not express the pain

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Benzydamine Hydrochloride
Benzydamine Hydrochloride application
• Normal saline
normal saline application

Locations
Country Name City State
Korea, Republic of SNUH Seoul Jongro Gu

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain application based pain score 30 minutes in postanesthetic care unit
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