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.

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  • Additional Information
    • Source:
      Publisher: American Academy of Pediatrics Country of Publication: United States NLM ID: 0376422 Publication Model: Print Cited Medium: Internet ISSN: 1098-4275 (Electronic) Linking ISSN: 00314005 NLM ISO Abbreviation: Pediatrics Subsets: MEDLINE
    • Publication Information:
      Publication: Elk Grove Village Il : American Academy of Pediatrics
      Original Publication: Springfield, Ill., Thomas.
    • Subject Terms:
      Catheterization, Peripheral*/adverse effects ; Drug Delivery Systems*/adverse effects ; Phlebotomy*/adverse effects; Analgesia/*methods ; Anesthetics, Local/*administration & dosage ; Lidocaine/*administration & dosage ; Pain/*prevention & control; Administration, Cutaneous ; Adolescent ; Anesthetics, Local/adverse effects ; Child ; Child, Preschool ; Double-Blind Method ; Female ; Humans ; Lidocaine/adverse effects ; Male ; Pain/etiology ; Pain Measurement ; Powders
    • 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.
    • Molecular Sequence:
      ClinicalTrials.gov NCT00140088
    • Accession Number:
      0 (Anesthetics, Local)
      0 (Powders)
      98PI200987 (Lidocaine)
    • Publication Date:
      Date Created: 20080503 Date Completed: 20080604 Latest Revision: 20131121
    • Publication Date:
      20231215
    • Accession Number:
      10.1542/peds.2007-0814
    • Accession Number:
      18450903