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Sponsored by: |
New York University School of Medicine |
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Information provided by: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00681902 |
The purpose of this study is to explore to what degree, if any, Jet lidocaine will reduce or alleviate pain, as compared to Jet normal saline, in children undergoing needle insertion in the Pediatric Emergency Department (PED). If effective, Jet lidocaine would afford a novel rapidly acting local anesthesic for children in the PED.
Condition | Intervention |
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Pain |
Drug: Lidocaine Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Jet Lidocaine for Pain Relief During Needle Insertion in a Pediatric Emergency Department. |
Estimated Enrollment: | 168 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | July 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Jet lidocaine
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Drug: Lidocaine
Jet lidocaine compared to jet placebo before needle insertion
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2: Placebo Comparator
Jet saline
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Drug: Placebo
Jet saline
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Ages Eligible for Study: | 5 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Bellevue Hospital | Recruiting |
New York, New York, United States, 10016 | |
Contact: Michael Mojica, MD 212-562-3025 | |
Contact: Michael Tunik, MD | |
Sub-Investigator: Marc Auerbach, MD | |
Sub-Investigator: Michael Tunik, MD |
Principal Investigator: | Michael Mojica | NYU/Bellevue |
Responsible Party: | Department of Pediatrics, NYUSOM ( Marc Auerbach, Fellow Pediatric Emergency Medicine ) |
Study ID Numbers: | 06-705 |
Study First Received: | May 19, 2008 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00681902 |
Health Authority: | United States: Institutional Review Board |
Pediatric Pain Needle Emergency Phlebotomy |
Intravenous Lidocaine Local Anesthesia |
Lidocaine Emergencies Pain |
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 |