search
Back to results

Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients

Primary Purpose

Intubation Complication

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Benzydamine Hydrochloride
Normal saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intubation Complication

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • general anesthesia
  • intubation require

Exclusion Criteria:

  • recent upper airway infection
  • could not express the pain

Sites / Locations

  • SNUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control

benzydamine hydrochloride

Arm Description

normal saline

Benzydamine Hydrochloride

Outcomes

Primary Outcome Measures

pain
application based pain score

Secondary Outcome Measures

Full Information

First Posted
February 26, 2017
Last Updated
April 9, 2018
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03074968
Brief Title
Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients
Official Title
Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
March 13, 2018 (Actual)
Study Completion Date
April 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation Complication

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Placebo Comparator
Arm Description
normal saline
Arm Title
benzydamine hydrochloride
Arm Type
Active Comparator
Arm Description
Benzydamine Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Benzydamine Hydrochloride
Other Intervention Name(s)
difflam
Intervention Description
Benzydamine Hydrochloride application
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
ns
Intervention Description
normal saline application
Primary Outcome Measure Information:
Title
pain
Description
application based pain score
Time Frame
30 minutes in postanesthetic care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: general anesthesia intubation require Exclusion Criteria: recent upper airway infection could not express the pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Soo Kim
Organizational Affiliation
Seoul National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SNUH
City
Seoul
State/Province
Jongro Gu
ZIP/Postal Code
15710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32247315
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients

We'll reach out to this number within 24 hrs