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Sponsored by: |
ZARS Pharma Inc. |
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Information provided by: | ZARS Pharma Inc. |
ClinicalTrials.gov Identifier: | NCT00125255 |
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 |
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Pain |
Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 80 |
Study Start Date: | June 2005 |
Ages Eligible for Study: | 5 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Children's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Susan T. Verghese, MD | Childrens Research Institute |
Principal Investigator: | Navil Sethna, MD | Children's Hospital |
Principal Investigator: | Andrew Wiznia, MD | Jacobi Medical Center |
Study ID Numbers: | SCP-46-05 |
Study First Received: | July 27, 2005 |
Last Updated: | October 5, 2005 |
ClinicalTrials.gov Identifier: | NCT00125255 |
Health Authority: | United States: Food and Drug Administration |
Tetracaine Lidocaine Pain |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Cardiovascular Agents |
Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |