ABSTRACT
OBJECTIVE: To assess the pharmacokinetics and clinical tolerance of a 33% cocaine solution administered topically for intranasal surgery. STUDY DESIGN: Clinical prospective open trial. PATIENTS AND METHODS: Twelve ASA I patients scheduled for intranasal surgery were sedated with midazolam 2 mg and fentanyl 50 micrograms. Topical anaesthesia was obtained with aqueous 33% cocaine HCl 360 mg, lidocaine HCl 140 mg, adrenaline 0.04 mg and naphazoline 0.4 mg. Venous blood samples were taken before cocaine application and 15, 30, 45, 60, 90, 120, 150, 180, 240 min later. The plasma was immediately separated and the samples were frozen. The concentration of cocaine was measured by HPLC. Potential cardiotoxic and neurotoxic effects were clinically monitored. RESULTS: The mean dose of cocaine applied was 5.85 +/- 1.3 mg.kg-1 and the dose actually delivered was 4 +/- 1.5 mg.kg-1. The Cmax was 859 +/- 503 ng.mL-1 after a Tmax to 47 +/- 17 min. The mean elimination half-life was 87 +/- 19 min (mean +/- SD). The total clearance and the volume of distribution were respectively 4,521 +/- 1,858 mL.min-1 and 568 +/- 273 L. No clinical evidence of toxicity was found. CONCLUSIONS: This study shows that it is possible to perform major intranasal surgery under topical anaesthesia with a concentrated solution (33%) of cocaine at a high dose (6 mg.kg-1). These results differ completely with data obtained in addicts.
