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Sponsors and Collaborators: |
Anesiva, Inc. Covance |
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Information provided by: | Anesiva, Inc. |
ClinicalTrials.gov Identifier: | NCT00766181 |
The purpose of this study is to determine the satisfaction among parents and nurses of pediatric patients with IV catheter placement in the Emergency Department.
Condition | Intervention |
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Intravenous Placement Procedure |
Behavioral: Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system |
Study Type: | Observational |
Study Design: | Cohort, Cross-Sectional |
Official Title: | An Evaluation of Parent and Nurse Satisfaction Associated With Pediatric Peripheral Intravenous Catheter Placement Using Standard of Care vs. ZingoTM in the Emergency Department |
Estimated Enrollment: | 200 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1: Lifestyle
Observatonal
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2: Lifestyle
Observational
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Behavioral: Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system
0.5 mg lidocaine hydrochloride
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The objectives of this study are to evaluate whether the proportion of parents satisfied with their child's IV placement procedure is higher after the introduction of Zingo compared to standard of care and to evaluate changes in nursing staff satisfaction with performing IV placement procedures after using Zingo prior to IV placement compared to standard of care.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Pediatric patients in Emergency Department requiring peripheral IV catheter placement.
Inclusion Criteria:
Exclusion Criteria:
- Parent of patient with a serious unstable medical or psychological condition that would compromise participation in the study
Responsible Party: | Anesiva, Inc. ( Mitra Sadeghi, Pharm.D. ) |
Study ID Numbers: | 113-03P |
Study First Received: | October 1, 2008 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00766181 |
Health Authority: | United States: Institutional Review Board |
IV placement; Parent satisfaction level |
Lidocaine Emergencies |
Disease Attributes Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Cardiovascular Agents Anesthetics, Local Pharmacologic Actions |
Pathologic Processes Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Anti-Arrhythmia Agents Central Nervous System Agents |