title: 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.
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.
authors.affiliation: Department of Pediatrics, University of Connecticut School of Medicine and Connecticut Children's Medical Center, Hartford, Connecticut 06106, USA. wzempsk@ccmckids.org
authors.forename: William T
authors.initials: WT
authors.lastname: Zempsky
authors.forename: Jolene
authors.initials: J
authors.lastname: Bean-Lijewski
authors.forename: Ralph E
authors.initials: RE
authors.lastname: Kauffman
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Koh
authors.forename: Shobha V
authors.initials: SV
authors.lastname: Malviya
authors.forename: John B
authors.initials: JB
authors.lastname: Rose
authors.forename: Patricia T
authors.initials: PT
authors.lastname: Richards
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Gennevois
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000698:Analgesia / Q000379:methods*; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000009:adverse effects; D002406:Catheterization, Peripheral / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D016503:Drug Delivery Systems / Q000009:adverse effects; D005260:Female; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D010147:Pain Measurement; D018962:Phlebotomy / Q000009:adverse effects; D011208:Powders
chemical_list: D000779:Anesthetics, Local; D011208:Powders; D008012:Lidocaine