Home » Drug Information » FDA-Approved Drugs » 2007
Medical Areas: Pediatrics/Neonatology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Anesiva
Approval Status: Approved August 2007
Treatment Area: local analgesia prior to venipuncture or peripheral intravenous cannulation, in children 3 to 18 years of age
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.
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.
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
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 or local analgesia
prior to venipuncture or peripheral intravenous cannulation, please
visit the Zingo
web page.