Effect of Clove Oil and Menthol Lozenges on Post-extubation Sore Throat

February 2, 2025 updated by: Cagla Toprak, Atlas University

Effects of Clove Oil and Menthol-containing Lozenges in Preventing Post-extubation Sore Throat in Patients Undergoing Surgical Intervention

In patients undergoing surgical intervention, endotracheal intubation, which is a part of the anesthesia procedure, can cause postoperative sore throat in patients. This situation causes difficulty in swallowing, inadequate nutrition and fluid intake, and prolongs the recovery process. In addition, sore throat is defined as a source of physical stress, which can lead to an increase in the incidence of postoperative morbidity and a decrease in patient satisfaction. This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat after surgery. Our aim was to provide evidence on the effectiveness of simple, low-cost menthol and clove oil lozenges in reducing sore throat after extubation, thus helping the patient recover.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat in patients after surgery.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34147
        • Bakirkoy Dr. Sadi Konuk Training and Research Hospital
    • Kağıthane
      • İstanbul, Kağıthane, Turkey
        • Istanbul Atlas University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between the ages of 18-65. Having had abdominal surgery. Being extubated within the first 8 hours after surgery. ASA class I-III. Mallampati class I-II. Glasgow Coma Scale (GCS) score 15

Exclusion Criteria:

  • History of allergies.

    • Severe nausea and vomiting.
    • Being extubated after the first 8 hours after surgery.
    • Communication disorders
    • Mallampati class III-IV.
    • Glasgow Coma Scale (GCS) score <15

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Menthol Group Patients
Patients in the menthol group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out.
Biological: Menthol lozenge
Patients in the menthol group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out.
Experimental: Clove lozenge group
Patients in the clove group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out.
Biological: Clove lozenge
Patients in the clove group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out.
Placebo Comparator: Control Group
Before routine clinical procedures after surgery, the patients in the control group will fill out the Patient introduction form, Patient follow-up form, and Numerical pain scale. After 60 minutes after extubation; clinical procedures do not include any procedures or interventions and the patient follow-up form and Numerical pain scale will be evaluated. After 120 minutes after extubation; the patient follow-up form and numerical pain scale will be evaluated.
Other: None-placebo
Before routine clinical procedures after surgery, the patients in the control group will fill out the Patient introduction form, Patient follow-up form, and Numerical pain scale. After 60 minutes after extubation; clinical procedures do not include any procedures or interventions and the patient follow-up form and Numerical pain scale will be evaluated. After 120 minutes after extubation; the patient follow-up form and numerical pain scale will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS pain score
Time Frame: Pain was assessed at 4 time points, immediately before the first application (baseline) and 30 minutes after application of each of the three lozenges (T1, T2, T3).
Sore throat pain will be measured by VAS score: zero mean NO PAIN, 10 means unsupportable pain.
Pain was assessed at 4 time points, immediately before the first application (baseline) and 30 minutes after application of each of the three lozenges (T1, T2, T3).
sore throat
Time Frame: 60 minutes after extubation
VAS is used to make measurable some values that cannot be measured numerically, evaluated by individuals by marking them on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end of which indicates that the individual is "very bad".
60 minutes after extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sore throat
Time Frame: 90 minutes after extubation
VAS is used to make measurable some values that cannot be measured numerically, evaluated by individuals by marking them on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end of which indicates that the individual is "very bad".
90 minutes after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlas University

Collaborators

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2025

Primary Completion (Estimated)

October 15, 2025

Study Completion (Estimated)

November 15, 2025

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 2, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CToprak

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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