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 Citations (Scopus)

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
StatePublished - May 2008

Fingerprint

Phlebotomy
Lidocaine
Catheterization
Powders
Analgesia
Needles
Placebos
Pain
Visual Analog Scale
Therapeutics
Parents
Facial Pain
Purpura
Erythema
Epidermis
Self Report
Hand
Pediatrics
Safety
Pressure

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

Cite this

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

In: Pediatrics, Vol. 121, No. 5, 05.2008, p. 979-987.

Research output: Contribution to journalArticle

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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.",
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AU - Zempsky, William T.

AU - Bean-Lijewski, Jolene

AU - Kauffman, Ralph E.

AU - Koh, Jeffrey

AU - Malviya, Shobha V.

AU - Rose, John B.

AU - Richards, Patricia T.

AU - Gennevois, Daniel J.

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N2 - 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.

AB - 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.

KW - Lidocaine

KW - Local anesthetics

KW - Medical device

KW - Pain assessment

KW - Peripheral cannulation

KW - Transdermal administration

KW - Venipuncture

KW - Visual analog scale

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