Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00125255
First received: July 27, 2005
Last updated: June 4, 2012
Last verified: June 2012

July 27, 2005
June 4, 2012
June 2005
October 2005   (final data collection date for primary outcome measure)
Pain Intensity [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT00125255 on ClinicalTrials.gov Archive Site
Number of participants with adverse events [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel
To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel.
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • 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 Name: Pliaglis
  • Drug: Placebo Peel
    Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 30 minutes
    Other Name: Placebo
  • Experimental: S-Caine Peel
    Intervention: Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
  • Placebo Comparator: Placebo Peel
    Intervention: Drug: Placebo Peel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
October 2005
October 2005   (final data collection date for primary outcome measure)

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.
Both
5 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00125255
SCP-46-05
No
ZARS Pharma Inc.
ZARS Pharma Inc.
Not Provided
Principal Investigator: Susan T. Verghese, MD Children's Research Institute
Principal Investigator: Navil Sethna, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Andrew Wiznia, MD Jacobi Medical Center
ZARS Pharma Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP