S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Vascular Access Procedures in Children
Condition: Pain
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%); Placebo Peel
Intervention type(s): Drug; Drug
Intervention description(s): S-Caine Peel comprising of a 1:1 eutectic mixture of 7% lidocaine and 7% tetracaine was applied topically. The study drug was applied at approximately 1 mm in thickness and remained on the treatment area for 30 minutes; Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 30 minutes
Other intervention name(s): Pliaglis; Placebo
Intervention MeSH terms: Lidocaine; Tetracaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment