Safety and Efficacy of Needle-free Powder Lidocaine Delivery System in Adult Patients Undergoing Venipuncture or Peripheral Venous Cannulation: A Randomized, Double-Blind, Placebo-controlled Trial.

Abstract

The purpose of this study was to evaluate the efficacy, safety, and tolerability of a needle-free powder lidocaine delivery system compared with sham placebo in adults. Adult patients participated in this multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Patients were randomly allocated to receive either the needle-free powder lidocaine delivery system or sham placebo 1 to 3 minutes before a required venipuncture or venous cannulation. The primary efficacy endpoint measured the analgesic effect of the active system using a pain visual analogue scale. In 693 adults who completed the study, the needle-free powder lidocaine delivery system was associated with significantly less pain during venipuncture and venous cannulation compared with sham placebo, as demonstrated by a difference between groups in age-adjusted mean pain score (P=0.003). Secondary analyses demonstrating significant differences between groups included the proportion of patients who were pain free, the proportion of responders, and the difference between pain experienced during the current venous procedure compared with the recollection of pain experienced during a prior venous procedure. Use of the active system was not associated with any serious adverse events or any adverse events resulting in study discontinuation. All treatment-related adverse events were mild. This clinical trial demonstrated that use of a needle-free powder lidocaine delivery system resulted in a significant reduction of pain during venipuncture and peripheral intravenous cannulation in adults. Both the predefined primary endpoint and all 3 secondary endpoints were met. The needle-free powder lidocaine delivery system may be an option for analgesia during venous access procedures in adults.