ABSTRACT
PURPOSE: Results of efficacy and safety assessments of topical sevoflurane use in patients with long-term treatment-refractory vascular ulcers are reported. METHODS: Patients were randomly assigned to receive sevoflurane instillations (1 mL per cm2 of ulcer area 1-4 times daily) plus standard wound care (ulcer cleaning, debridement, and dressing changes) or standard care only. Topical sevoflurane was initiated during hospitalization, with self- or nurse-administered instillations continued after discharge. Study participants were evaluated at least once weekly for 1 month and then every 2 weeks for up to 90 days. The primary efficacy measures were debridement-related and overall pain (assessed using a 10-point visual analog scale), daily opioid use, and ulcer size; secondary measures were patient and clinician impressions of improvement and ulcer-related admissions during treatment. The primary safety endpoint was intolerable sevoflurane-related adverse effects. RESULTS: Compared with the group receiving standard care alone (n = 5), the sevoflurane group (n = 10) had significant (p = 0.001) reductions in mean ± S.D. scores for debridement-related pain on day 1 of treatment and at subsequent time points; the sevoflurane group also had significant reductions in overall pain, daily opioid use, and ulcer size. Outcomes in terms of patient- and clinician-rated improvement and emergency admissions also favored the sevoflurane group. Mild localized reddening in the area surrounding ulcers occurred in 4 sevoflurane-treated patients. CONCLUSION: Direct application of sevoflurane onto vascular ulcers resulted in an intense and long-lasting analgesia and was associated with a progressive reduction of ulcer size.
