Back to resultsPost-operative Sore Throat and Gum Chewing
Primary Purpose
Anesthesia, Surgery
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gum
Control
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia
Eligibility Criteria
Inclusion Criteria:
- Outpatient ambulatory surgery
- General anesthesia utilizing a laryngeal mask airway
- Greater than 1 hour duration
Exclusion Criteria:
- Chronic laryngitis
- Chronic bronchitis
- Asthma
- Gastroesophageal reflux disease
- Smoking within the last week
- Non-English speaking
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Gum
Control
Arm Description
Group 1 will receive gum immediately prior to transport to the operating room. They will be asked to chew the gum for 2 minutes and then spit the gum in the garbage.
Group 2 will not receive any gum. They will be asked to swallow twice and have no other intervention.
Outcomes
Primary Outcome Measures
Incidence of moderate to severe Post-operative Sore Throat within 24 hours
Moderate to severe post-operative sore throat defined as greater than 3 on an 11-point Numeric Rating Scale; 0 being no sore throat, 10 being maximum imaginable sore throat
Secondary Outcome Measures
Satisfaction with Anesthesia
5-point likert scale; very satisfied, satisfied, neutral, dissatisfied, very dissatisfied
Full Information
NCT ID
NCT04859101
First Posted
April 21, 2021
Last Updated
September 11, 2022
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT04859101
Brief Title
Post-operative Sore Throat and Gum Chewing
Official Title
Post-operative Sore Throat and Gum Chewing for Long Duration LMA Use: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if chewing gum immediately prior to transport to the operating room reduces the severity of post-operative sore throat in patients who have an LMA (laryngeal mask airway) placed for procedures with duration greater than 1 hour.
Detailed Description
Patients will be randomized into two groups. Group 1 will receive a piece of gum immediately prior to transport to the operating room. They will be asked to chew the gum for 2 minutes and then spit the gum in the garbage. Group 2 will not receive any gum. They will be asked to swallow twice and have no other intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gum
Arm Type
Experimental
Arm Description
Group 1 will receive gum immediately prior to transport to the operating room. They will be asked to chew the gum for 2 minutes and then spit the gum in the garbage.
Arm Title
Control
Arm Type
Other
Arm Description
Group 2 will not receive any gum. They will be asked to swallow twice and have no other intervention.
Intervention Type
Other
Intervention Name(s)
Gum
Intervention Description
2 minutes of gum chewing prior to procedure
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
2 swallows prior to procedure
Primary Outcome Measure Information:
Title
Incidence of moderate to severe Post-operative Sore Throat within 24 hours
Description
Moderate to severe post-operative sore throat defined as greater than 3 on an 11-point Numeric Rating Scale; 0 being no sore throat, 10 being maximum imaginable sore throat
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Satisfaction with Anesthesia
Description
5-point likert scale; very satisfied, satisfied, neutral, dissatisfied, very dissatisfied
Time Frame
24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Outpatient ambulatory surgery
General anesthesia utilizing a laryngeal mask airway
Greater than 1 hour duration
Exclusion Criteria:
Chronic laryngitis
Chronic bronchitis
Asthma
Gastroesophageal reflux disease
Smoking within the last week
Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob L Hutchins, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-operative Sore Throat and Gum Chewing
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