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
About this trial
This is an interventional other trial for Intubation Complication
Eligibility Criteria
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
NCT ID
NCT03074968
First Posted
February 26, 2017
Last Updated
April 9, 2018
Sponsor
Seoul National University Hospital
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
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