Safety and Efficacy of Needle-free Powder XXXX Delivery System in Adult @entity1 Undergoing Venipuncture or Peripheral Venous Cannulation: A Randomized, Double-Blind, Placebo-controlled Trial.

@entity1 @entity3303 @entity158
OBJECTIVES: The purpose of this study was to evaluate the efficacy, safety, and tolerability of a needle-free powder @entity3303 delivery system compared with sham placebo in adults. METHODS: Adult @entity1 participated in this multicenter, randomized, double-blind, placebo-controlled, parallel-group study. @entity1 were randomly allocated to receive either the needle-free powder @entity3303 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 @entity158 visual analogue scale. RESULTS: In 693 adults who completed the study, the needle-free powder @entity3303 delivery system was associated with significantly less @entity158 during venipuncture and venous cannulation compared with sham placebo, as demonstrated by a difference between groups in age-adjusted mean @entity158 score (P=0.003). Secondary analyses demonstrating significant differences between groups included the proportion of @entity1 who were @entity158 free, the proportion of responders, and the difference between @entity158 experienced during the current venous procedure compared with the recollection of @entity158 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. DISCUSSION: This clinical trial demonstrated that use of a needle-free powder @entity3303 delivery system resulted in a significant @entity158 during venipuncture and peripheral intravenous cannulation in adults. Both the predefined primary endpoint and all 3 secondary endpoints were met. The needle-free powder @entity3303 delivery system may be an option for analgesia during venous access procedures in adults.
