S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Vascular Access Procedures in Children - Full Text View

Sponsored by:	ZARS Pharma Inc.
Information provided by:	ZARS Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00125255

Purpose

The pain associated with medical procedures is often under-treated in children. Children often undergo painful procedures with little or no anesthetic, even when effective therapy is available. Reasons for not providing available therapy in children include concerns over adverse side effects as well as the length of time necessary to provide adequate anesthesia. Recent guidelines strongly advocate for the proactive treatment of pain in children, including the pain associated with medical procedures.

S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to evaluate whether S-Caine Peel is effective in providing topical local dermal anesthesia prior to a vascular access procedure in children 5 through 17 years of age.

Condition	Intervention	Phase
Pain	Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)	Phase III

MedlinePlus related topics: Anesthesia

Drug Information available for: Tetracaine Viractin Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo Controlled, Parallel Study Evaluating the Efficacy of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) for Induction of Local Dermal Anesthesia Before Vascular Access Procedures in Children

Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:

To evaluate the efficacy of S-Caine Peel in providing local dermal anesthesia before a venous vascular access procedure in children 5 through 17 years of age

Secondary Outcome Measures:

To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel

Estimated Enrollment:	80
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	5 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is 5 through 17 years of age.
Patient has a medical indication to undergo a venous vascular access procedure (excluding peripherally inserted central catheter [PICC] lines) on the antecubital surface.

Exclusion Criteria:

Patient is pregnant or breastfeeding.
Patient has participated in a clinical trial of an unapproved drug within the previous 30 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125255

Locations

United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

ZARS Pharma Inc.

Investigators

Principal Investigator:	Susan T. Verghese, MD	Childrens Research Institute
Principal Investigator:	Navil Sethna, MD	Children's Hospital
Principal Investigator:	Andrew Wiznia, MD	Jacobi Medical Center

More Information

Study ID Numbers:	SCP-46-05
Study First Received:	July 27, 2005
Last Updated:	October 5, 2005
ClinicalTrials.gov Identifier:	NCT00125255
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Tetracaine
Lidocaine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009