Post-operative Sore Throat and Gum Chewing

Not Applicable

Completed

• Conditions: Anesthesia; Surgery
• Interventions: Other: Gum; Other: Control

• Registration Number: NCT04859101
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-26
• Study Start: 2021-07-21
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-11
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Outpatient ambulatory surgery
• General anesthesia utilizing a laryngeal mask airway
• Greater than 1 hour duration

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Exclusion Criteria

• Chronic laryngitis
• Chronic bronchitis
• Asthma
• Gastroesophageal reflux disease
• Smoking within the last week
• Non-English speaking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gum	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.
Control	Control	Group 2 will not receive any gum. They will be asked to swallow twice and have no other intervention.

Primary Outcome Measures

Name	Time	Method
Incidence of moderate to severe Post-operative Sore Throat within 24 hours	24 hour	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

Name	Time	Method
Satisfaction with Anesthesia	24 hour	5-point likert scale; very satisfied, satisfied, neutral, dissatisfied, very dissatisfied

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States