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
  Purpose

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.


Condition Intervention Phase
Pain
Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
Drug: Placebo Peel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 81
Study Start Date: June 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125255

Locations
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00125255     History of Changes
Other Study ID Numbers: SCP-46-05
Study First Received: July 27, 2005
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014