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

A Randomized, Double-blind, Placebo Controlled, Parallel Study Evaluating the Efficacy of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) for Induction of Local Dermal Anesthesia Before Vascular Access Procedures in Children

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%); Drug: Placebo Peel

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: S-Caine Peel	Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%); 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; Other Names: Pliaglis
PLACEBO_COMPARATOR: Placebo Peel	Drug: Placebo Peel; Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 30 minutes; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	The primary efficacy variable was pain intensity as reported by the patient using the Colored Analog Scale (CAS) (scale 0 to 10), a validated tool for measuring pain in children.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel	30 minutes

Collaborators and Investigators

• Sponsor: ZARS Pharma Inc.
• Investigators: Principal Investigator: Susan T. Verghese, MD, Children's National Research Institute; Principal Investigator: Navil Sethna, MD, Children's Hospital Medical Center, Cincinnati; Principal Investigator: Andrew Wiznia, MD, Jacobi Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (ACTUAL): October 1, 2005
• Study Completion (ACTUAL): October 1, 2005

Study Registration Dates

• First Submitted: July 27, 2005
• First Submitted That Met QC Criteria: July 27, 2005
• First Posted (ESTIMATE): July 29, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): June 6, 2012
• Last Update Submitted That Met QC Criteria: June 4, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Tetracaine
• Other Study ID Numbers: SCP-46-05