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.
This was a randomized, double-blind, placebo-controlled, parallel study that evaluated the
effectiveness of S-Caine Peel in providing local dermal anesthesia for vascular access
procedures in children who were 5 through 17 years of age. Patients were randomized 1:1 to
receive either one application of S-Caine Peel or one application of placebo for 30 minutes
prior to a vascular access procedure.
During the screening visit, the study was fully explained to each patient's legal guardian
and written informed consent was obtained. Whenever possible, patients provided assent.
The screening visit also included: evaluating eligibility criteria; obtaining a medical
history (including skin type, demographic data, and concomitant medications); obtaining a
brief physical examination and urine pregnancy test (for females of childbearing potential),
which had to be negative for the patient to enroll in the study; and providing patient
education on how to assess pain using the Colored Analog Scale (CAS). The screening visit
could occur on the same day as the procedure visit.
Upon meeting the eligibility criteria and completing the screening visit, patients were
assigned the next available sequential patient number in their age group (5-11 years or
12-17 years). Based upon a randomized code, patients were randomized to receive either S
Caine Peel or placebo for 30 minutes before the scheduled vascular access procedure.
The study drug application site could be on either the patient's left or right antecubital
surface and covered an area of 10 cm2. A thin layer (approximately 1 mm or the thickness of
a dime) of the study drug was applied evenly across the area to be treated for 30 minutes.
Immediately following removal of the study drug, the study drug application site was
evaluated for erythema, edema, blanching or other skin reactions. The vascular access
procedure was then performed.
Upon completion of the vascular access procedure, the investigator's evaluation of
procedural pain intensity and assessment of the adequacy of the anesthesia provided by the
study drug were completed. Following these assessments, patients assessed their procedural
pain intensity using the CAS. All pain evaluations were completed after the first attempt
to gain vascular access. If the first attempt was unsuccessful and further attempts were
required, the procedure was stopped and all pain assessments were performed before further
attempts at vascular access were made.
- 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
- Patient is pregnant or breastfeeding.
- Patient has participated in a clinical trial of an unapproved drug within the
previous 30 days.