Need for Intravenous CatheterPhase 2NCT00552695
Lidocaine Patches Prior to Intravenous Insertion
A Phase 2 study testing Lidocaine tetracaine in people with Need for Intravenous Catheter, run by Stony Brook University at 1 site in United States.
Trial summary
This study will determine whether application of a patch containing a topical anesthetic (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an intravenous catheter in Emergency Department patients. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Need for Intravenous Catheter
- What is being tested?
- Lidocaine tetracaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jan 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 3,
- Need for non-emergent intravenous catheter
Who cannot join
- Unstable patients,
- Allergy to lidocaine or tetracaine
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
Official title: Phase II Study of Lidoderm Patches Prior to Intravenous Catheter Insertion.
This study will determine whether application of a patch containing a topical anesthetic (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an intravenous catheter in Emergency Department patients.
Read the detailed description
Patients will be randomly assigned to an active lidocaine patch or a patch that conatins a placebo or inactive agent. Neither the patient nor the practitioner will know which patch is used since they will appear identical.
- Conditions
- Need for Intravenous Catheter
- Being tested
- Lidocaine tetracaine, Placebo
- Keywords
- intravenous catheter, emergency department, pain
- Medical subject headings
- Emergencies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine tetracaineDevice
Also called Synera
Lidocaine 70 mg/tetracaine 70 mg
PlaceboDevice
Placebo patch identical in appearance to Synera
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Lidocaine 70 mg/tetracaine 70 mg skin patch Receives: Device: Lidocaine tetracaine |
| 2 | Placebo comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on Visual Analog Scale (VAS)
Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).
Measured: 0 MINUTES
Secondary outcomes (1)
Success of Intravenous (IV) Insertion
Percentage of patients in whom intravenous catheter was inserted successfully
Measured: After first attempt of catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Need for Intravenous CatheterStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Singer, Stony Brook University
- Investigators
- Adam J Singer, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552695
- Sponsor's protocol ID
- 20076689
- Status last verified
- Oct 2012
- First submitted
- 31 Oct 2007
- Last updated
- 22 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Lidoderm Patches Prior to Intravenous Catheter Insertion.
- ClinicalTrials.gov ID
- NCT00552695
- Acronym / sponsor ID
- 20076689
- Conditions
- Need for Intravenous Catheter
- Keywords
- intravenous catheter, emergency department, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 2 Nov 2007 (estimated)
- Results
- Posted 6 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether application of a patch containing a topical anesthetic (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an intravenous catheter in Emergency Department patients.
Detailed description
Patients will be randomly assigned to an active lidocaine patch or a patch that conatins a placebo or inactive agent. Neither the patient nor the practitioner will know which patch is used since they will appear identical.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Lidocaine tetracaineLidocaine 70 mg/tetracaine 70 mg skin patch |
| 2 | Placebo comparator | Device: Placebo |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to 3,
- Need for non-emergent intravenous catheter
Key exclusion criteria (2 listed)
- Unstable patients,
- Allergy to lidocaine or tetracaine
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 |
|---|---|---|
| Lidocaine tetracaineAlso: SyneraLidocaine 70 mg/tetracaine 70 mg | Device | 1 |
| PlaceboPlacebo patch identical in appearance to Synera | Device | 2 |
Primary outcome
Pain on Visual Analog Scale (VAS)
Time frame: 0 MINUTES
Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).
1 secondary outcome
Success of Intravenous (IV) Insertion
Time frame: After first attempt of catheter insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Need for Intravenous Catheter
Not yet recruiting
Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial
Vascular Access Complication, Device Related Infection
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.
Adam J Singer, MD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine tetracaine in people with Need for Intravenous Catheter, run by Stony Brook University at 1 site in United States.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 22 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain on Visual Analog Scale (VAS) (time frame: 0 MINUTES). 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 22 Oct 2012.