Actinic Keratosis, Analgesia, Pain, Phototerapy, Vertex
Conditions
Brief 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)
Interventions
DRUGProcedure (Tumesent anesthesia)
Photodynamic therapy of vertex with a solution of 180 ml of tumescent anesthesia diffused over 1 hour in three different sub-deceasing points.
DRUGControl Arm (Paracetamol)
Photodynamic therapy of vertex with 1g of paracetamol intake 1 hour before cold water is applied during the session.
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Measure : evaluate the effectiveness of tumescent anesthesia compared to the control group in pain management during a dynamic vertex phototherapy session performed for the management of actinic keratoses. | 8 minutes | Score of the maximum numerical pain assessment scale from 0 to 10 (0=no pain; 10= pain as bas as can be) felt during the dynamic phototherapy session in both groups. This score will be collected at the end of the session. |
Countries
France
Contacts
Primary ContactDamien BOUTIN, Dr
Outcome results
None listed