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

NCT00125255 | Completed Phase 3

• 1 other identifier: SCP-46-05
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with adverse events

  30 minutes

Study Arms (2)

S-Caine Peel

EXPERIMENTAL

Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)

Placebo Peel

PLACEBO COMPARATOR

Drug: Placebo Peel

Interventions

S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) DRUG

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

Also known as: Pliaglis

S-Caine Peel

Placebo Peel DRUG

Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 30 minutes

Also known as: Placebo

Placebo Peel

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• ZARS Pharma Inc.: lead

Study Sites (1)

Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2005
• First Posted: July 29, 2005
• Study Start: June 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

US (1)