The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: Anesiva
Approval Status: Approved August 2007
Treatment for: local analgesia prior to venipuncture or peripheral intravenous cannulation, in children 3 to 18 years of age
General Information
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 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.
Clinical Results
FDA Approval
FDA approval of Zingo was based on the results of two clinical trials. 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).
Study One
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.
Study Two
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.
Side Effects
Adverse events associated with the use of Zingo may include, but are not limited to, the following:
- Erythema
- Edema
- Pruritus
- Petechiae
- Bruising
- Burning
- Pain
- Contusion
- Hemorrhage
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.
Literature References
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
Additional Information
For additional information regarding Zingo or local analgesia prior to venipuncture or peripheral intravenous cannulation, please visit the Zingo web page.
