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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT00125255

Run by

ZARS Pharma Inc.

People needed

81

Starts

2005-06-01

Expected to finish

2005-10-01

Last updated by the study team

2012-06-06

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.