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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071240105
Enrollment
20
Registered
2025-02-03
Start date
2025-02-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glossodynia

Interventions

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 requir

Sponsors

Tachi Mizuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Contacts

Public ContactMizuki Tachi

Nagasaki University Hospital

m-tachi@nagasaki-u.ac.jp+81-958197714

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026