Post-operative Sore Throat and Gum Chewing

NCT ID: NCT04859101

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-21

Study Completion Date

2022-05-01

Brief Summary

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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

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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.

Conditions

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Anesthesia Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Gum

Intervention Type OTHER

2 minutes of gum chewing prior to procedure

Control

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

Group Type OTHER

Control

Intervention Type OTHER

2 swallows prior to procedure

Interventions

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Gum

2 minutes of gum chewing prior to procedure

Intervention Type OTHER

Control

2 swallows prior to procedure

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob L Hutchins, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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ANES-2021-29683

Identifier Type: -

Identifier Source: org_study_id

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