Needlefree lidocaine study

June 7, 2008

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This study by Zempsky et al (2008) compares needle-free powder lidocaine with a placebo. Readers may also be interested in reading about Zingo in our product section.

Zempsky W.T., Bean-Lijewski J., Kauffman R.E., Koh J.L., Malviya S.V., Rose J.B., Richards P.T. and Gennevois D.J. (2008) Needle-free powder lidocaine delivery system provides rapid effective analgesia for venipuncture or cannulation pain in children: randomized, double-blind comparison of venipuncture and venous cannulation pain after fast-onset needle-free powder lidocaine or placebo treatment trial. Pediatrics. 121(5), p.979-987.

Abstract:

“The Comparison of Venipuncture and Venous Cannulation Pain After Fast-Onset Needle-Free Powder Lidocaine or Placebo Treatment trial was a randomized, single-dose, double-blind, phase 3 study investigating whether a needle-free powder lidocaine delivery system (a sterile, prefilled, disposable system that delivers lidocaine powder into the epidermis) produces effective local analgesia within 1 to 3 minutes of venipuncture and peripheral venous cannulation procedures in children. Pediatric patients (3-18 years of age) were randomly assigned to treatment with the needle-free powder lidocaine delivery system (0.5 mg of lidocaine and 21 +/- 1 bar of pressure; n = 292) or a sham placebo system (n = 287) at the antecubital fossa or the back of the hand 1 to 3 minutes before venipuncture or cannulation. All patients rated the administration comfort of the needle-free systems and the pain of the subsequent venous access procedures with the Wong-Baker Faces Pain Rating Scale (from 0 to 5). Patients 8 to 18 years of age also provided self-reports with a visual analog scale, and parents provided observational visual analog scale scores for their child’s venous access pain. Safety also was assessed. Immediately after administration, mean Wong-Baker Faces scale scores were 0.54 and 0.24 in the active system and sham placebo system groups, respectively. After venipuncture or cannulation, mean Wong-Baker Faces scale scores were 1.77 +/- 0.09 and 2.10 +/- 0.09 and mean visual analog scale scores were 22.62 +/- 1.80 mm and 31.97 +/- 1.82 mm in the active system and sham placebo system groups, respectively. Parents’ assessments of their child’s procedural pain were also lower in the active system group (21.35 +/- 1.43 vs 28.67 +/- 1.66). Treatment-related adverse events were generally mild and resolved without sequelae. Erythema and petechiae were more frequent in the active system group. The needle-free powder lidocaine delivery system was well tolerated and produced significant analgesia within 1 to 3 minutes” (Zempsky et al 2008).