Zingo (lidocaine hydrochloride monohydrate)Company: Powder Pharmaceuticals
Approval Status: Approved August 2007
Treatment for: local analgesia prior to venipuncture or peripheral intravenous cannulation
Areas: Neurology & Nervous System; Pediatrics
Zingo (lidocaine hydrochloride monohydrate) is a powder intradermal injection system. It delivers lidocaine hydrochloride monohydrate into the dermis. Lidocaine is an amide-type local anesthetic agent that blocks sodium ion channels required for the initiation and conduction of neuronal impulses, resulting in local anesthesia.
Zingo is specifically indicated for use on intact skin to provide local analgesia prior to venipuncture or peripheral intravenous cannulation in adults and in children 3-18 years of age, and to avoid pain associated with venous access procedures.
Zingo is supplied as a powder injection system for intradermal administration. The recommended initial dose of the drug is 0.5 mg applied one to three minutes prior to needle insertion.
FDA approval of Zingo was based on the results of two clinical trials in pediatrics and a single trial in adults.
These randomized, double-blind, parallel-arm, sham-placebo controlled studies enrolled subjects 3-18 years of age. The population included healthy subjects as well as those with acute and chronic medical conditions. The subjects received Zingo or a placebo device at the back of hand or antecubital fossa, between one and three minutes prior to venipuncture or peripheral venous cannulation. Measurements of pain were made immediately following the venous procedure. Efficacy was measured using a modified version of the Wong-Baker FACES pain rating scale ranging from 0 (no hurt) to 5 (hurts worst).
The Adjusted Mean, least squares mean (LSM) for the Zingo group was 1.77 and for the placebo group 2.10, for a difference in LSMs of -0.33 (0.13) and 95% confidence limits of -0.58, -0.08, respectively.
The Adjusted Mean, least squares mean (LSM) for the Zingo group was 1.38 and for the placebo group 1.77, for a difference in LSM's of -0.39 (0.13) and 95% confidence limits of -0.65 and -0.13, respectively.
The efficacy of Zingo in adults was evaluated in a randomized, double-blind, parallel-arm, sham-placebo controlled trial in which adult patients who required a venipuncture or peripheral venous cannulation received either Zingo or a sham placebo device. Patients were treated with Zingo or a placebo device at the antecubital fossa or back of the hand, between one and three minutes prior to venipuncture or peripheral venous cannulation. Measurements of pain were made immediately following the procedure. Efficacy was measured using a continuous 100 mm visual analogue scale ranging from 0 (“no pain”) to 100 (“worst possible pain”). Many of the patients had chronic medical problems such as depression, hypertension, hypothyroidism, and hyperlipidemia and over one fourth of the population may have been at higher than average risk of dermal bleeding due to use of concomitant medications such as NSAIDs, aspirin, and corticosteroids. Treatment with active drug resulted in less pain compared with placebo. Adjusted Mean, LSM: Zingo: 11.61 and placebo: 16.23. Difference in LSMs (SE2): -4.62 (1.55). 95% Confidence Limits -7.67, -1.57. However, efficacy was primarily seen in patients undergoing venipuncture at the antecubital fossa, while patients undergoing cannulation at the back of the hand did not demonstrate a difference between active and sham administrations.
Adverse events associated with the use of Zingo may include, but are not limited to, the following:
Mechanism of Action
Zingo (lidocaine hydrochloride monohydrate) is a powder intradermal injection system. It delivers lidocaine hydrochloride monohydrate into the dermis. Lidocaine is an amide-type local anesthetic agent that blocks sodium ion channels required for the initiation and conduction of neuronal impulses, resulting in local anesthesia. Zingo provides local dermal analgesia within 1-3 minutes of application. Analgesia diminishes within 10 minutes of treatment.
Migdal M, Chudzynska-Pomianowska E, Vause E, Henry E, Lazar J Rapid, needle-free delivery of lidocaine for reducing the pain of venipuncture among pediatric subjects. Pediatrics 2005 Apr;115(4):e393-8
Zempsky WT, Sullivan J, Paulson DM, Hoath SB.Clinical therapeutics 2004 Jul;26(7):1110-9
Rose JB, Galinkin JL, Jantzen EC, Chiavacci RM A study of lidocaine iontophoresis for pediatric venipuncture. Anesthesia and Analgesia 2002 Apr;94(4):867-71
For additional information regarding Zingo, please visit www.powderpharma.com
Zingo Drug Information
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