Satisfaction With Pediatric Intravenous Catheter Placement in the Emergency Department

An Evaluation of Parent and Nurse Satisfaction Associated With Pediatric Peripheral Intravenous Catheter Placement Using Standard of Care vs. ZingoTM in the Emergency Department

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.

Study Overview

• Status: Terminated
• Conditions: Intravenous Placement Procedure
• Intervention / Treatment: Behavioral: Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients in Emergency Department requiring peripheral IV catheter placement.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1: Lifestyle; Observatonal
2: Lifestyle; Observational	Behavioral: Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system; 0.5 mg lidocaine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Parent's satisfaction with IV placement procedure	18 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Nurse'e satisfaction with performing IV placement	18 weeks

Collaborators and Investigators

• Sponsor: Anesiva, Inc.
• Collaborators: Covance

Publications and helpful links

Helpful Links

• Anesiva home page
• Zingo Product Information

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ANTICIPATED): February 1, 2009
• Study Completion (ANTICIPATED): April 1, 2009

Study Registration Dates

• First Submitted: October 1, 2008
• First Submitted That Met QC Criteria: October 2, 2008
• First Posted (ESTIMATE): October 3, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 25, 2010
• Last Update Submitted That Met QC Criteria: May 24, 2010
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: IV placement; Parent satisfaction level
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 113-03P