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Sore Throat Prevention Following Intubation

Primary Purpose

Sore Throat

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
xylocaine
Dexamethasone
Xylocaine and Dexamethasone
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sore Throat focused on measuring Sore Throat, Intubation, Xylocaine, Dexamethasone

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA 1-3.
  • Elective VS Emergency.
  • Cuffed endo-tracheal tubes.
  • Different types of surgery.

Exclusion Criteria:

  • Pregnant ladies.
  • ICU patients.
  • <15 years of age
  • Laryngeal mask airway

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Xylocaine "X"

    Dexamethasone "D"

    xylocaine and dexamethasone "XD"

    Arm Description

    Patients received xylocaine gel as lubricant on endotracheal tube

    Patients were given dexamethasone 8 mg intravenously

    Patients were given both xylocaine gel and dexamethasone 8 mg intravenously

    Outcomes

    Primary Outcome Measures

    Comparison in preventing sore throat: xylocaine gel versus dexamethasone or both following intubation.
    Questionnaire follow up in intubated patients.

    Secondary Outcome Measures

    Sore throat SCALE
    Sore throat scale from None,mild,moderate till severe.

    Full Information

    First Posted
    February 5, 2016
    Last Updated
    February 10, 2016
    Sponsor
    University of Jordan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02682134
    Brief Title
    Sore Throat Prevention Following Intubation
    Official Title
    Comparison Between Xylocaine Gel as Endotracheal Cuff Lubricant Versus Dexamethasone 8 mg Intravenously or Both for Sore Throat Prevention Following Intubation: Interventional Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Jordan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this interventional study is to find out the incidence of sore throat among intubated patients in Jordan university hospital and to find out which is preventive and effective method to decrease sore throat;is it xylocaine gel on endotracheal cuff as lubricant versus dexamethasone 8 mg intravenously or both.
    Detailed Description
    Three groups were divided into: first group received xylocaine gel as endotracheal cuff lubricant,second group received dexamethasone 8 mg intravenously and third group received both( xylocaine and dexamethasone). The investigator compared between the three groups regarding sore throat in intubated patients and followed them up to 48 hours.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sore Throat
    Keywords
    Sore Throat, Intubation, Xylocaine, Dexamethasone

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    300 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Xylocaine "X"
    Arm Type
    Experimental
    Arm Description
    Patients received xylocaine gel as lubricant on endotracheal tube
    Arm Title
    Dexamethasone "D"
    Arm Type
    Experimental
    Arm Description
    Patients were given dexamethasone 8 mg intravenously
    Arm Title
    xylocaine and dexamethasone "XD"
    Arm Type
    Experimental
    Arm Description
    Patients were given both xylocaine gel and dexamethasone 8 mg intravenously
    Intervention Type
    Drug
    Intervention Name(s)
    xylocaine
    Other Intervention Name(s)
    X
    Intervention Description
    First group were given xylocaine
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Other Intervention Name(s)
    D
    Intervention Description
    Second group were given Dexamethasone
    Intervention Type
    Drug
    Intervention Name(s)
    Xylocaine and Dexamethasone
    Other Intervention Name(s)
    XD
    Intervention Description
    Third group were given both Xylocaine and Dexamethasone
    Primary Outcome Measure Information:
    Title
    Comparison in preventing sore throat: xylocaine gel versus dexamethasone or both following intubation.
    Description
    Questionnaire follow up in intubated patients.
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Sore throat SCALE
    Description
    Sore throat scale from None,mild,moderate till severe.
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA 1-3. Elective VS Emergency. Cuffed endo-tracheal tubes. Different types of surgery. Exclusion Criteria: Pregnant ladies. ICU patients. <15 years of age Laryngeal mask airway
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aboud Aljabari
    Organizational Affiliation
    University of Jordan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Sore Throat Prevention Following Intubation

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