This Phase 3 study, called COMFORT-003 (Comparison of Venipuncture and Venous Cannulation Pain After Fast-Onset Needle-free Powder Lidocaine or Placebo Treatment), demonstrated Zingo's rapid onset of action, allowing peripheral venous access procedures, such as IV insertions or blood draws, to begin one to three minutes after administration.(1) Guidelines from the American Academy of Pediatrics, the American Pain Society and the Infusion Nurses Society have all recommended use of topical anesthetics prior to venous access procedures(5), but since many currently available local anesthetics take 20 minutes or longer to become effective, they're often difficult to use in a fast-paced hospital environment. According to a national survey of Pediatric Emergency Department Fellowship Directors, current topical anesthetics are used for only 38 percent of IV placements in children.(6)
The study was a randomized, double-blind, placebo-controlled, single-dose, Phase 3 study to assess efficacy and safety. It compared 292 patients from age three to 18 who received Zingo with a group of 287 patients who were treated with a sham placebo device that did not administer medication.(1)
Zingo demonstrated a statistically significant reduction in pain by all
-- Patients receiving Zingo reported less pain (1.77) compared to
patients in the control group (2.10) by children's self report using
the Wong-Baker Faces scale (p=0.011).
-- A secondary measure of pain, the visual analog scale (VAS), was also
used in patients eight to 18 years old, and patients who received
Zingo also reported significantly lower VAS scores (22.62) compared to
sham placebo (31.97) (p<0.001).
-- Parents of patients who received Zingo also rat
|SOURCE Anesiva, Inc.|
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