Post-operative Sore Throat and Gum Chewing

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04859101
• Other study ID #: ANES-2021-29683
• Status: Completed
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: September 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 1, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Pharyngitis
• Surgery

Intervention

Other:
• Gum
2 minutes of gum chewing prior to procedure
• Control
2 swallows prior to procedure

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Satisfaction with Anesthesia	5-point likert scale; very satisfied, satisfied, neutral, dissatisfied, very dissatisfied	24 hour