Pain Clinical Trial
— ANTUKAOfficial title:
Tumescent Anesthesia Interest in Pain Management During a Dynamic Phototherapy (PTD) Session in Vertex Actinic Keratosis Treatment: a Single-center Prospective Randomized Study
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)
Status | Recruiting |
Enrollment | 48 |
Est. completion date | November 2022 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU | Poitiers |
Lead Sponsor | Collaborator |
---|---|
Poitiers University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. |
8 minutes |
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