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

Further Study Details: 

Primary Outcomes: 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 Outcomes: To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel.
Expected Total Enrollment:  80

Ages Eligible for Study:  5 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patient is 5 through 17 years of age.
• Patient has a medical indication to undergo a venous vascular access procedure (excluding 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00125255

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

Study chairs or principal investigators

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

Study ID Numbers:  SCP-46-05
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125255
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02