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    Needle-free System Saves Time, Tears

    By Jennifer Huddleston, staff writer   

    Data from a study published in the May 2008 edition of Pediatrics, the journal of the American Academy of Pediatrics, gives hope to parents of children who fear the stick of a doctor’s needle.

    The study, called COMFORT-003 (Comparison of Venipuncture and Venous Cannulation Pain after Fast-onset Needle-free Powder Lidocaine or Placebo Treatment), was a double-blind, placebo-controlled, single-dose Phase 3 study that researched the effectiveness and safety of a needle-free system called Zingo. [1]

    Zingo, developed by San Francisco-based biopharmaceutical company Anesiva, administers 0.5 mg of lidocaine hydrochloride monohydrate powder intradermally through a single-use, helium-powered pressure injector and takes effect in one to three minutes. [2]

    Findings associate system with reduced pain

    Researchers compared 292 pediatric patients ages 3 to 18 who received treatment with Zingo with a group of 287 patients who were treated with a placebo device that did not administer anesthesia while undergoing venous access procedures, including drawing blood (phlebotomy) and intravenous (IV) line placement. [3]

    The results of the study showed that treatment with Zingo was associated with significantly less pain during IV placement and while drawing blood than when a placebo was used. Using the Wong-Baker Faces scale, patients treated with Zingo reported less pain than those in the control group. Patients who used Zingo also reported lower pain scores on the visual analog scale (VAS) compared to those who received the placebo. The study also found that the prevalence of adverse events with Zingo was no higher than with the placebo. [4]

    The side effects of Zingo are those related to general lidocaine use, which include red spots (petechiae), swelling (edema), redness (erythema) and itching at the application site. Because the lidocaine used with Zingo is in powder form, “there’s no liquid, so there’s no burning,” said William T. Zempsky, associate professor of Pediatrics and Emergency Medicine at the University of Connecticut and associate director of Connecticut Children’s Medical Center Pain Relief Program, who led the study. [5]  

    To date, the study is the largest published trial on local anesthetic use for venous access procedures in children. [6]

    “Nothing like that on the market”

    Guidelines and recommendations set forth by the American Academy of Pediatrics, the American Pain Society and the Infusion Nurses Society include the usage of topical anesthetics before venous access procedures. [7] Despite those recommendations and guidelines, a national survey of Pediatric Emergency Department Fellowship Directors found that current topical anesthetics are used in just 38 percent of pediatric IV placements. [8]

    Venous access procedures are the most common interventions in hospitals, with more than 18 million pediatric procedures each year in the U.S. [9] A 2006 Impulse Research survey conducted by Anesiva revealed that 70 percent of children experience fear and stress during office or hospital visits that involve a venous access procedure. Further, more than half of all pediatric patients cry during those procedures, something the needle-free system strives to alleviate. [10]  

    Zingo provides the safety and reduced pain of lidocaine with faster onset and less effort than local anesthetics currently available. [11] Anesthetics currently available take up to 20 minutes to take effect, making it difficult to use them in fast-paced medical settings such as hospitals. [12] Zingo can be used in hospitals as well as physicians’ offices and clinical labs. [13]

    “It really didn’t interrupt the flow of the procedure at all. You deliver the drug, you turn around, you get your tourniquet, you put it on and you put your needle in,” Zempsky said. “There’s nothing like that on the market currently.” [14]  

    The Food and Drug Administration approved Zingo in 2007 based on the results of the COMFORT-003 study. [15] While the system is currently only approved for children ages 3 to 18 undergoing venous access procedures, Anesiva is looking to expand the approval to include adult use. [16] In March 2008 the company submitted a supplemental New Drug Application with the FDA to allow the use of Zingo in venous access procedures for adults. [17]  


    [1]  Anesiva Announces Publication of Phase 3 Zingo™ Data in the Journal Pediatrics. Medical News Today. May 6, 2008.

    [2] Lamel, Ellen. New Product Could Allow Painless Peds Injections. Emergency Physicians Monthly. Oct. 1, 2007.

    [3]  Anesiva Announces Publication of Phase 3 Zingo™ Data in the Journal Pediatrics. Medical News Today. May 6, 2008.

    [4]  Ibid.

    [5] Lamel, Ellen. New Product Could Allow Painless Peds Injections. Emergency Physicians Monthly. Oct. 1, 2007.

    [6]  Anesiva Announces Publication of Phase 3 Zingo™ Data in the Journal Pediatrics. Medical News Today. May 6, 2008.

    [7]  FDA Approved Zingo to Reduce Pain Associated with Needle Insertion Procedures in Children. eMaxHealth.com. Aug. 18, 2007.

    [8]  Anesiva Announces Publication of Phase 3 Zingo™ Data in the Journal Pediatrics. Medical News Today. May 6, 2008.

    [9]  FDA Approved Zingo to Reduce Pain Associated with Needle Insertion Procedures in Children. eMaxHealth.com. Aug. 18, 2007.

    [10]  Ibid.

    [11] Lamel, Ellen. New Product Could Allow Painless Peds Injections. Emergency Physicians Monthly. Oct. 1, 2007.

    [12]  FDA Approved Zingo to Reduce Pain Associated with Needle Insertion Procedures in Children. eMaxHealth.com. Aug. 18, 2007.

    [13]  Ibid.

    [14] Lamel, Ellen. New Product Could Allow Painless Peds Injections. Emergency Physicians Monthly. Oct. 1, 2007.

    [15]  Anesiva Announces Publication of Phase 3 Zingo™ Data in the Journal Pediatrics. Medical News Today. May 6, 2008.

    [16] Lamel, Ellen. New Product Could Allow Painless Peds Injections. Emergency Physicians Monthly. Oct. 1, 2007.

    [17]  Anesiva Announces Publication of Phase 3 Zingo™ Data in the Journal Pediatrics. Medical News Today. May 6, 2008.



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