Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients

April 9, 2018 updated by: Hee-Soo Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • general anesthesia
  • intubation require

Exclusion Criteria:

  • recent upper airway infection
  • could not express the pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: control
normal saline
Drug: Normal saline
normal saline application
Other Names:
  • ns
ACTIVE_COMPARATOR: benzydamine hydrochloride
Benzydamine Hydrochloride
Drug: Benzydamine Hydrochloride
Benzydamine Hydrochloride application
Other Names:
  • difflam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain
Time Frame: 30 minutes in postanesthetic care unit
application based pain score
30 minutes in postanesthetic care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 8, 2017

Primary Completion (ACTUAL)

March 13, 2018

Study Completion (ACTUAL)

April 5, 2018

Study Registration Dates

First Submitted

February 26, 2017

First Submitted That Met QC Criteria

March 4, 2017

First Posted (ACTUAL)

March 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1612-061-813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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