Pilot Trial: Comparing Buzzy to Intradermal Lidocaine for Peripheral IV Cannulation in Adults
NCT ID: NCT04647084
Last Updated: 2023-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2022-10-15
2025-05-31
Brief Summary
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Detailed Description
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The investigators are conducting this study to compare the effectiveness of the Buzzy® device with that of the injection of numbing medication underneath the skin for IV placement in adults. This device has been FDA approved for use.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intradermal Lidocaine 2%
Lidocaine 2% Injectable Solution
An elastic band will be placed around the subject's arm, and the elastic band will be removed once the IV is inserted. After the elastic band is placed on the subject's arm, the arm will be cleaned, and then a small skin wheel will be created with the lidocaine that will be injected very close to where the IV will be placed. The IV will be placed within about a minute from the time when the lidocaine was injected.
Buzzy
Buzzy
The Buzzy vibrating ice pack will be placed on the subject's arm with an elastic band around it, and it will remain there as the arm is cleaned and prepped and the IV inserted. The Buzzy device will be removed once the IV is inserted.
Interventions
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Lidocaine 2% Injectable Solution
An elastic band will be placed around the subject's arm, and the elastic band will be removed once the IV is inserted. After the elastic band is placed on the subject's arm, the arm will be cleaned, and then a small skin wheel will be created with the lidocaine that will be injected very close to where the IV will be placed. The IV will be placed within about a minute from the time when the lidocaine was injected.
Buzzy
The Buzzy vibrating ice pack will be placed on the subject's arm with an elastic band around it, and it will remain there as the arm is cleaned and prepped and the IV inserted. The Buzzy device will be removed once the IV is inserted.
Eligibility Criteria
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Inclusion Criteria
2. Non-pregnant women and men
3. Adults that are able to consent
4. Patients requiring intravenous catheter insertion for their operation/procedure
Exclusion Criteria
18 Years
99 Years
ALL
Yes
Sponsors
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Steward St. Elizabeth's Medical Center of Boston, Inc.
OTHER
Responsible Party
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Principal Investigators
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Michael Schoor, MD
Role: PRINCIPAL_INVESTIGATOR
physician
Locations
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St. Elizabeth's Medical Center
Brighton, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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00808
Identifier Type: -
Identifier Source: org_study_id
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