An Early Phase 1 interventional study of Menthol lozenge and Clove lozenge in Sore Throat, sponsored by Atlas University. Enrolling by invitation at 2 sites in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Atlas University · Early Phase 1, Interventional, and Prevention
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.
This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat in patients after surgery.
226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's planned enrollment of 150 is close to the median of 144 across 188 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →Atlas University is the lead sponsor of 96 studies on the registry; 25 are open to participants now.
Compared within Pharyngitis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Exclusion Criteria:
History of allergies.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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
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.
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.
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.
VAS pain score
Sore throat pain will be measured by VAS score: zero mean NO PAIN, 10 means unsupportable pain.
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
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".
Time frame: 60 minutes after extubation
Sore throat
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".
Time frame: 90 minutes after extubation
Plan to share: No
Started Jan 2025 (actual). Primary completion is estimated for Oct 2025, 8 months after the start.
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Atlas University