Pain Management During a Photodynamic Therapy Session on the Vertex for Actinic Keratosis: Tumescent Anesthesia Interest

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study focus on the efficacity of tumescent anesthesia in pain management during a photodynamic therapy on the vertex for treatment of actinic keratosis. To do this we carried out a prospective, randomized, controlled, open-ended study. Our aim is to show a 40% reduction in pain during photodynamic therapy session compared to a conventionally used analgesic method (paracetamol + cold water)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poitiers University Hospital
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Patients over the age of 18

• Diagnosis of clinical or histological actintic keratoses validated by a dermatologist

• More than 4 vertex actinic keratoses lesions that can be treated with a dynamic phototherapy session

• Free subject, without guardianship or curatorship or subordination

• Person affiliated or beneficiary of a social security plan

• Informed and signed consent by the patient after clear and fair information about the study

Exclusion Criteria:

• Known lidocaine hydrochlostate hypersensitivity, local amide-binding anesthetics or one of the excipients

• Hypersensitivity to paracetamol or one of the excipients

• Weight < 50 kg

• Patients with an elongated TQ interval at the ECG (>450 ms in men and >470 ms in women)

• Patients with recurrent porphyria

• Severe hepato-cellular insufficient patients

• Patients who have received treatment for actinic keratoses in the last three months (cryotherapy, 5-fluorouracil, imiquinod, daylight-PTD)

• Patients who have already participated in this study

• People who do not have a social security plan or do not benefit from it through a third party.

• Persons with enhanced protection, namely minors, persons deprived of their liberty by judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally the sick in an emergency situation.

• Pregnant or lactating women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per bone, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).

• Concurrent participation in another clinical research study.