Intravenous Placement ProcedureNCT00766181
Satisfaction With Pediatric Intravenous Catheter Placement in the Emergency Department
An observational study of Intravenous Placement Procedure, run by Anesiva, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Intravenous Placement Procedure
- What is being tested?
- Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Pediatric patients in Emergency Department requiring peripheral IV catheter placement.
Who may be able to join
- 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
Who cannot join
- Parent of patient with a serious unstable medical or psychological condition that would compromise participation in the study
About this study
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
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.
Read the 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.
- Conditions
- Intravenous Placement Procedure
- Being tested
- Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system
- Keywords
- IV placement; Parent satisfaction level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection systemBehavioural
0.5 mg lidocaine hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| 1: Lifestyle | Observatonal | |
| 2: Lifestyle | Observational Receives: Behavioral: Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent's satisfaction with IV placement procedure
Measured: 18 weeks
Secondary outcomes (1)
Nurse'e satisfaction with performing IV placement
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2009 (estimated)
- Study completionApr 2009 (estimated)
Why it stopped: Product withdrawn from distribution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous Placement ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anesiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766181
- Sponsor's protocol ID
- 113-03P
- Status last verified
- Nov 2008
- First submitted
- 1 Oct 2008
- Last updated
- 25 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00766181
- Acronym / sponsor ID
- 113-03P
- Conditions
- Intravenous Placement Procedure
- Keywords
- IV placement; Parent satisfaction level
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Product withdrawn from distribution
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Anesiva, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Lifestyle | – | –Observatonal |
| 2: Lifestyle | – | Behavioral: Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection systemObservational |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pediatric patients in Emergency Department requiring peripheral IV catheter placement.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Parent of patient with a serious unstable medical or psychological condition that would compromise participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system0.5 mg lidocaine hydrochloride | Behavioural | 2: Lifestyle |
Primary outcome
Parent's satisfaction with IV placement procedure
Time frame: 18 weeks
1 secondary outcome
Nurse'e satisfaction with performing IV placement
Time frame: 18 weeks
Results and safety
The study was stopped early (reason given: Product withdrawn from distribution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2010.
- Anesiva home pageLink provided by the sponsor.
- Zingo Product InformationLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intravenous Placement Procedure, run by Anesiva, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Product withdrawn from distribution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent's satisfaction with IV placement procedure (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2010.