Clin J Pain. 2015 May 15
Authors: Zempsky WT1 et al
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 subjects participated in this multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Subjects were randomly allocated to receive either the needle-free powder lidocaine delivery system or sham placebo 1-3 minutes prior to a required venipuncture or venous cannulation. The primary efficacy endpoint measured the analgesic effect of the active system using a pain visual analog 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 subjects 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.