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

Early Phase 1

• Conditions: Sore Throat
• Interventions: Biological: Menthol lozenge; Biological: Clove lozenge; Other: None-placebo

• Registration Number: NCT06811051
• Lead Sponsor: Atlas University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2025-01-08
• Study Start: 2025-01-25
• Study First Submitted QC: 2025-02-02
• Last Update Submitted: 2025-02-02
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-10-15
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Menthol Group Patients	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.
Clove lozenge group	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.
Control Group	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.

Primary Outcome Measures

Name	Time	Method
VAS pain score	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.
sore throat	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".

Secondary Outcome Measures

Name	Time	Method
Sore throat	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".

Trial Locations

Locations (2)

İstanbul Atlas University; 🇹🇷 İstanbul, Kağıthane, Turkey

Bakirkoy Dr. Sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Turkey