drugset / Trial / NCT00125255

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

NCT00125255

Phase 3 Completed 81 enrolled ZARS Pharma Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2005-06
Primary completion
2005-10
Completion
2005-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 7 % Topical
Subject tetracaine Other / unclassified 7 % Topical

Indications

No indication recorded.