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

William T. Zempsky, Jolene Bean-Lijewski, Ralph E. Kauffman, Jeffrey Koh, Shobha V. Malviya, John B. Rose, Patricia T. Richards, Daniel J. Gennevois

Research output: Contribution to journalArticle

34 Scopus citations

Abstract

OBJECTIVE. 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 for venipuncture and peripheral venous cannulation procedures in children. METHODS. 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. RESULTS. 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. CONCLUSIONS. The needle-free powder lidocaine delivery system was well tolerated and produced significant analgesia within 1 to 3 minutes.

Original languageEnglish (US)
Pages (from-to)979-987
Number of pages9
JournalPediatrics
Volume121
Issue number5
DOIs
Publication statusPublished - May 2008

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Keywords

  • Lidocaine
  • Local anesthetics
  • Medical device
  • Pain assessment
  • Peripheral cannulation
  • Transdermal administration
  • Venipuncture
  • Visual analog scale

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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