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S.L. Spray Solution® and Difflam® and Acular®Spray for the Prevention of Postoperative Sore Throat

Primary Purpose

Sore Throat

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
S.L.®
Difflam Forte ®
Acular®
placebo
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sore Throat focused on measuring postoperative sore throat, American Society of Anesthesiologists status, general anesthesia, post-anesthesia care unit(PACU)

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. intubation for patients under general anesthesia
  2. age>20
  3. none pre-operative sore throat
  4. by the researchers explain research purposes, the researchers agreed to participate

Exclusion Criteria:

  1. postoperative on N-G tube
  2. Surgical side is located by the mouth or throat
  3. thyroidectomy
  4. difficult airway
  5. none extubation at PACU
  6. on patient-controlled analgesia
  7. the medical records have a history of nonsteroidal antiinflammatory drugs allergy
  8. medical records have kidney disease or a history of renal dysfunction
  9. peptic ulcer
  10. pregnancy or lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Placebo Comparator

    Active Comparator

    Experimental

    Arm Label

    S.L.® & Difflam Forte ®

    placebo ( for Acular® )

    Acular® & S.L.®

    Difflam Forte ® & Acular®

    Arm Description

    "1.5 mg/ml Benzydamine" , "S.L.® Spray Solution" 2.5 mg and "3.0 mg/ml Benzydamine" ,Difflam Forte ® 5.0 mg spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.

    placebo(distilled water)spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.

    "5% Ketorolac Tromethamine" , "Acular®" 8.0 mg and "1.5 mg/ml Benzydamine" , "S.L.® Spray Solution" 2.5 mg spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.

    "3.0 mg/ml Benzydamine" , "Difflam Forte ®" 5.0 mg and "5% Ketorolac Tromethamine" "Acular®" 8.0 mg spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.

    Outcomes

    Primary Outcome Measures

    pain scale (Numeric Rating Scale: 0-10)

    Secondary Outcome Measures

    nonsteroidal antiinflammatory drug side effect

    Full Information

    First Posted
    October 16, 2015
    Last Updated
    May 20, 2021
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02608788
    Brief Title
    S.L. Spray Solution® and Difflam® and Acular®Spray for the Prevention of Postoperative Sore Throat
    Official Title
    Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of intubation for patients under general anesthesia is to maintain their respiratory function. However, this procedure does cause a postoperative sore throat. Comfort of patients could be promoted if effective treatment could be found. The specific aims of this project are: Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam to Release Postoperative Sore Throat. Acular spray for the prevention of postoperative sore throat. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat.
    Detailed Description
    This is a quasi-experimental study with purposive sampling. Patients were distributed into the four groups (1.5mg / ml Benzydamine hydrochloride, 3.0mg / ml Benzydamine hydrochloride, 5%Ketorolac Tromethamine) by the operative room. Research tools including pain scale (Numeric Rating Scale: 0-10), drugs and case data record sheet. Collected information was managed by SPSS for Windows (version 21.0) statistical software package. Both the descriptive and Inferential statistics were performed. Sample homogeneity among the four groups were verified by F-test and chi-square test. generalized estimating equation was selected to compare the throat pain in the four points of assessment. The specific aims of this project are: Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam to Release Postoperative Sore Throat. Acular spray for the prevention of postoperative sore throat. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular to Release Postoperative Sore Throat.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sore Throat
    Keywords
    postoperative sore throat, American Society of Anesthesiologists status, general anesthesia, post-anesthesia care unit(PACU)

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    380 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    S.L.® & Difflam Forte ®
    Arm Type
    Active Comparator
    Arm Description
    "1.5 mg/ml Benzydamine" , "S.L.® Spray Solution" 2.5 mg and "3.0 mg/ml Benzydamine" ,Difflam Forte ® 5.0 mg spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.
    Arm Title
    placebo ( for Acular® )
    Arm Type
    Placebo Comparator
    Arm Description
    placebo(distilled water)spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.
    Arm Title
    Acular® & S.L.®
    Arm Type
    Active Comparator
    Arm Description
    "5% Ketorolac Tromethamine" , "Acular®" 8.0 mg and "1.5 mg/ml Benzydamine" , "S.L.® Spray Solution" 2.5 mg spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.
    Arm Title
    Difflam Forte ® & Acular®
    Arm Type
    Experimental
    Arm Description
    "3.0 mg/ml Benzydamine" , "Difflam Forte ®" 5.0 mg and "5% Ketorolac Tromethamine" "Acular®" 8.0 mg spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.
    Intervention Type
    Drug
    Intervention Name(s)
    S.L.®
    Other Intervention Name(s)
    Andolex®
    Intervention Description
    "1.5mg/ml Benzydamine hydrochloride"," S.L.®" spray by mouth . Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.
    Intervention Type
    Drug
    Intervention Name(s)
    Difflam Forte ®
    Other Intervention Name(s)
    Tantum Verde®
    Intervention Description
    "3.0mg/ml Benzydamine hydrochloride" , " Difflam Forte ®" spray by mouth . Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.
    Intervention Type
    Drug
    Intervention Name(s)
    Acular®
    Other Intervention Name(s)
    Apo-Ketorolac® Ophthalmic
    Intervention Description
    "5% Ketorolac Tromethamine" , " Acular® " spray by mouth . Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Other Intervention Name(s)
    distilled water
    Intervention Description
    Distilled water spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.
    Primary Outcome Measure Information:
    Title
    pain scale (Numeric Rating Scale: 0-10)
    Time Frame
    1.5 year
    Secondary Outcome Measure Information:
    Title
    nonsteroidal antiinflammatory drug side effect
    Time Frame
    1.5 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: intubation for patients under general anesthesia age>20 none pre-operative sore throat by the researchers explain research purposes, the researchers agreed to participate Exclusion Criteria: postoperative on N-G tube Surgical side is located by the mouth or throat thyroidectomy difficult airway none extubation at PACU on patient-controlled analgesia the medical records have a history of nonsteroidal antiinflammatory drugs allergy medical records have kidney disease or a history of renal dysfunction peptic ulcer pregnancy or lactation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hsiu-Ling Yang, RN, MS
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20304980
    Citation
    Hung NK, Wu CT, Chan SM, Lu CH, Huang YS, Yeh CC, Lee MS, Cherng CH. Effect on postoperative sore throat of spraying the endotracheal tube cuff with benzydamine hydrochloride, 10% lidocaine, and 2% lidocaine. Anesth Analg. 2010 Oct;111(4):882-6. doi: 10.1213/ANE.0b013e3181d4854e. Epub 2010 Mar 19.
    Results Reference
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    S.L. Spray Solution® and Difflam® and Acular®Spray for the Prevention of Postoperative Sore Throat

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