Post-operative Sore Throat and Gum Chewing

Post-operative Sore Throat and Gum Chewing for Long Duration LMA Use: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Anesthesia
• Intervention / Treatment: Other: Gum; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gum; 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.	Other: Gum; 2 minutes of gum chewing prior to procedure
Other: Control; Group 2 will not receive any gum. They will be asked to swallow twice and have no other intervention.	Other: Control; 2 swallows prior to procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with Anesthesia	5-point likert scale; very satisfied, satisfied, neutral, dissatisfied, very dissatisfied	24 hour

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jacob L Hutchins, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 11, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis
• Other Study ID Numbers: ANES-2021-29683

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No