Topical application of lidocaine jelly for symptomatic relief of glossodynia and its safety

JRCT ID: jRCTs071240105

Registered date:03/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: glossodynia
• Date of first enrollment: 03/02/2025
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Patients who present to the Oral Pain Liaison Outpatient Clinic of Nagasaki University Hospital for the first time or return visit with a chief complaint of glossodynia and who are diagnosed as requiring pain relief treatment will be the study subjects.
Study subjects will be assigned to Group 1 or Group 2 by randomized assignment. Study subjects will not be informed which group they are assigned to (single-blind).
The subjects assigned to Group 1 will be evaluated for pain associated with labialgia by applying an anesthetic patch with 2% Lidocaine jelly (clinical research drug) to the surface of the tongue where the patient complains of the most severe pain during the first treatment for 15 minutes. After a washout period of one to two months, a placebo patch with a medical lubricant jelly (control) applied to the same area will be applied for 15 minutes and the pain of glossodynia will be evaluated.
The subjects assigned to Group 2 will be evaluated for pain associated with labialgia by applying a placebo patch with a medical lubricant jelly (control) to the surface of the tongue where the patient complains of the most severe pain during the first treatment for 15 minutes. After a washout period of one to two months, an anesthetic patch with 2% Lidocaine jelly (clinical research drug) applied to the same area will be applied for 15 minutes and the pain of glossodynia will be evaluated.
Glossodynia pain will be assessed using the patient's own Visual Analogue Scale (VAS) assessment. The pain level assessed during the previous observation period (the patient's most severe pain complaint) will be used as the base value, and the VAS values immediately before the application of the clinical research drug and control drug to the tongue surface, immediately after the application 5 minutes later, 10 minutes later, and 30 minutes after the application will be recorded. The VAS values after returning home (before going to bed and upon waking up the next day) will be recorded on a recording form given to the patient and brought to the clinic on a later visit.

Outcome(s)

• Primary Outcome: The primary endpoint will be the evaluation of tongue pain (patient's own assessment) using the Visual Analogue Scale (VAS). The degree of pain assessed during the entire observation period (one location where the patient complains of the most pain) will be used as the basic value, and the VAS values will be recorded 5, 10, and 30 minutes after the clinical research drug and control drug are applied to the tongue surface, and the patient will return home after the anesthetic patch is removed. The VAS values after returning home (before going to bed and upon waking up the next day) will be recorded on a recording form given to the patient and brought to the clinic on a later visit.

Secondary Outcome

Ask about the following side effects and discomfort associated with the application of the drug
(1) Does the patient feel discomfort at the site of drug application?(Yes or No)
(2) Do you feel drowsy, anxious, or agitated?(Yes or No)
(3) Nausea(Yes or No)
(4) Any symptoms of itchiness on the body(Yes or No)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

(i) Patients with a first or second visit to the Oral Pain Liaison Outpatient Clinic of Nagasaki University Hospital with a chief complaint of glossodynia, diagnosed as requiring pain relief treatment with a pain VAS rating of 2 or higher.
ii) Age: Adult patients who are between 18 and 85 years of age at the time of consent.
(iii) Gender: any gender
(iv)Inpatient/Outpatient: Outpatient only
(v) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding.

Exclude criteria

(i) Patients with poor general condition
(ii) Patients with cardiac stimulation conduction disorder
(iii) Patients with serious renal dysfunction
(iv)Patients with severe hepatic dysfunction
(v) Pregnant women
(vi) Nursing mothers
(vii) Patients with lidocaine allergy
(viii) Patients who are judged to be inappropriate as research subjects by the investigator.

Related Information

• Primary Sponsor: Tachi Mizuki