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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 27, 2005

Last Updated Date

October 5, 2005

Start Date ^†

June 2005

Current 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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00125255 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Pain

Intervention ^†

Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

5 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00125255

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

ZARS Pharma Inc.

Collaborators ^††

Investigators ^†

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

Information Provided By

ZARS Pharma Inc.

Verification Date

October 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.