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Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03074968
Collaborator
(none)
142
Enrollment
1
Location
2
Arms
12.9
Actual Duration (Months)
11
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Benzydamine Hydrochloride
  • Drug: Normal saline
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
142 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients: a Randomized Controlled Trial
Actual Study Start Date :
Mar 8, 2017
Actual Primary Completion Date :
Mar 13, 2018
Actual Study Completion Date :
Apr 5, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pain [30 minutes in postanesthetic care unit]

      application based pain score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • general anesthesia

    • intubation require

    Exclusion Criteria:

    • recent upper airway infection

    • could not express the pain

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SNUH Seoul Jongro Gu Korea, Republic of 15710

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Hee-Soo Kim, Seoul National University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hee-Soo Kim, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03074968
    Other Study ID Numbers:
    • H1612-061-813
    First Posted:
    Mar 9, 2017
    Last Update Posted:
    Apr 11, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Pharyngitis
    Benzydamine

    Study Results

    No Results Posted as of Apr 11, 2018