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.