Satisfaction With Pediatric Intravenous Catheter Placement in the Emergency Department - Full Text View

Sponsors and Collaborators:	Anesiva, Inc. Covance
Information provided by:	Anesiva, Inc.
ClinicalTrials.gov Identifier:	NCT00766181

Purpose

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
Intravenous Placement Procedure	Behavioral: Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system

Drug Information available for: Lidocaine

U.S. FDA Resources

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

Further study details as provided by Anesiva, Inc.:

Primary Outcome Measures:

Parent's satisfaction with IV placement procedure [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Nurse'e satisfaction with performing IV placement [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
1: Lifestyle Observatonal
2: Lifestyle Observational	Behavioral: Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system 0.5 mg lidocaine hydrochloride

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pediatric patients in Emergency Department requiring peripheral IV catheter placement.

Criteria

Inclusion Criteria:

PHASE A: Parent of a pediatric patient from the age of 3 to 18 years of age who requires a peripheral IV placement in the Emergency Department
Parent must be able to read and understand English and provide written informed consent
Parent must be present during the IV placement
PHASE B: Parent did not participate in Phase A
Nurse has completed Zingo TM in-service training prior to participation
Zingo is used prior to performing the IV placement procedure

Exclusion Criteria:

- Parent of patient with a serious unstable medical or psychological condition that would compromise participation in the study

Contacts and Locations

No Contacts or Locations Provided

More Information

Anesiva home page This link exits the ClinicalTrials.gov site

Zingo Product Information This link exits the ClinicalTrials.gov site

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

Keywords provided by Anesiva, Inc.:

IV placement; Parent satisfaction level

Study placed in the following topic categories:

Lidocaine
Emergencies

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009