NCT00766181

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 25, 2010

Status Verified

November 1, 2008

Enrollment Period

4 months

First QC Date

October 1, 2008

Last Update Submit

May 24, 2010

Conditions

Intravenous Placement Procedure

Keywords

IV placement; Parent satisfaction level

Outcome Measures

Primary Outcomes (1)

  • Parent's satisfaction with IV placement procedure

    18 weeks

Secondary Outcomes (1)

  • Nurse'e satisfaction with performing IV placement

    18 weeks

Study Arms (2)

1: Lifestyle

Observatonal

2: Lifestyle

Observational

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

Interventions

Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection systemBEHAVIORAL

0.5 mg lidocaine hydrochloride

2: Lifestyle

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients in Emergency Department requiring peripheral IV catheter placement.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 1, 2008

First Posted

October 3, 2008

Study Start

October 1, 2008

Primary Completion

February 1, 2009

Study Completion

April 1, 2009

Last Updated

May 25, 2010

Record last verified: 2008-11