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

Poitiers University Hospital

Status: Unknown

Conditions: Phototerapy; Actinic Keratosis; Analgesia; Pain; Vertex

Treatments: Drug: Procedure (Tumesent anesthesia); Drug: Control Arm (Paracetamol)

Study type: Interventional

Funder types: Other

Identifiers

NCT04779255

2021-000304-38

Details and patient eligibility

About

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)

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Tumescent anesthesia

Experimental group

Description:

Patient who will receive tumescent anesthesia as analgesic treatment

Treatment:

Drug: Procedure (Tumesent anesthesia)

Painkillers and cold water

Active Comparator group

Description:

Patient who will receive painkillers 1 hour before photodynamic therapy and cold water during session as analgesic treatment

Treatment:

Drug: Control Arm (Paracetamol)