Published online May 1, 2008
PEDIATRICS Vol. 121 No. 5 May 2008, pp. 979-987 (doi:10.1542/peds.2007-0814)

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ARTICLE

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, MD^a, Jolene Bean-Lijewski, MD, PhD^b, Ralph E. Kauffman, MD^c, Jeffrey L. Koh, MD, MBA^d, Shobha V. Malviya, MD^e, John B. Rose, MD^f, Patricia T. Richards, MD, PhD^g and Daniel J. Gennevois, MD^g

^a Department of Pediatrics, University of Connecticut School of Medicine and Connecticut Children's Medical Center, Hartford, Connecticut
^b Department of Anesthesiolgy, Scott and White Memorial Hospital, Temple, Texas
^c Department of Medical Research, Children's Mercy Hospitals and Clinics, Kansas City, Missouri
^d Department of Anesthesiology and Perioperative Medicine, Oregon Health and Science University, Portland, Oregon
^e Department of Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan
^f Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
^g Anesiva, South San Francisco, California

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.

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Key Words: lidocaine • transdermal administration • local anesthetics • venipuncture • peripheral cannulation • pain assessment • visual analog scale • medical device

Abbreviations: AE—adverse event • ANOVA—analysis of variance • COMFORT—Comparison of Venipuncture and Venous Cannulation Pain After Fast-Onset Needle-Free Powder Lidocaine or Placebo Treatment • VAS—visual analog scale

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Accepted Sep 7, 2007.

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