NCT04779255

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

Tumescent Anesthesia Interest in Pain Management During a Dynamic Phototherapy (PTD) Session in Vertex Actinic Keratosis Treatment: a Single-center Prospective Randomized Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Pain
• Actinic Keratosis
• Analgesia
• Phototerapy
• Vertex

Interventions

Type	Name	Description
DRUG	Procedure (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.
DRUG	Control Arm (Paracetamol)	Photodynamic therapy of vertex with 1g of paracetamol intake 1 hour before cold water is applied during the session.

Timeline

• Start date: 2021-07-28
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2021-03-03
• Last updated: 2021-09-29

Locations

1 site across 1 country: France