Pilot Trial: Comparing Buzzy to Intradermal Lidocaine for Peripheral IV Cannulation in Adults
Primary Purpose
Pain, Acute, Patient Satisfaction
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine 2% Injectable Solution
Buzzy
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Acute
Eligibility Criteria
Inclusion Criteria:
- Adults ages 18 to 99
- Non-pregnant women and men
- Adults that are able to consent
- Patients requiring intravenous catheter insertion for their operation/procedure
Exclusion Criteria:
-
Sites / Locations
- St. Elizabeth's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intradermal Lidocaine 2%
Buzzy
Arm Description
Outcomes
Primary Outcome Measures
Pain with IV Cannulation based on the Visual Analog Scale
How much pain do adult patients experience with peripheral IV cannulation when Buzzy® device is used versus when intradermal lidocaine 2% is used? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Secondary Outcome Measures
Satisfaction with IV cannulation based on the Numerical Rating Scale
How much satisfaction do adult patients experience with peripheral IV cannulation when Buzzy® device is used versus when intradermal lidocaine 2% is used? The Numerical Rating Scale is used for linear measurement of satisfaction, where the minimum number is 1 (very dissatisfied) and the maximum number is 5 (very satisfied).
Number of IV cannulation attempts
How does first attempt during peripheral intravenous cannulation in adult patients compare when Buzzy® device is used versus when intradermal lidocaine 2% is used?
Pain related to IV size based on the Visual Analog Scale
Does size of the peripheral intravenous catheter affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Pain related to IV location based on the Visual Analog Scale
Does location of the peripheral intravenous catheter placement affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Full Information
NCT ID
NCT04647084
First Posted
November 17, 2020
Last Updated
August 16, 2023
Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04647084
Brief Title
Pilot Trial: Comparing Buzzy to Intradermal Lidocaine for Peripheral IV Cannulation in Adults
Official Title
Pilot Randomized Control Trial: Comparing the Effectiveness of Buzzy Versus Intradermal Lidocaine for Peripheral Intravenous Cannulation in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The investigators were unable to begin work on this study.
Study Start Date
October 15, 2022 (Anticipated)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
IV placement is necessary for surgical procedures. Unfortunately, some patients say that placing an IV is painful. The investigators are conducting this study to evaluate two techniques that could make the placement of the IV more comfortable.
Detailed Description
Currently, some medical providers administer the IV without any pain-relieving techniques. Some medical providers inject a numbing medication underneath the skin prior to the IV placement. This requires an additional needle stick. Some medical providers place a device called Buzzy® on a patient's arm prior to the IV placement. The Buzzy® device is the combination of an ice pack and a vibrator in the shape of a bumble bee. Literature shows that the Buzzy® device makes IV placement more comfortable for children, but there is minimal data in regard to whether it is helpful for adult patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Patient Satisfaction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intradermal Lidocaine 2%
Arm Type
Experimental
Arm Title
Buzzy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lidocaine 2% Injectable Solution
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Buzzy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain with IV Cannulation based on the Visual Analog Scale
Description
How much pain do adult patients experience with peripheral IV cannulation when Buzzy® device is used versus when intradermal lidocaine 2% is used? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Time Frame
5-20 minutes
Secondary Outcome Measure Information:
Title
Satisfaction with IV cannulation based on the Numerical Rating Scale
Description
How much satisfaction do adult patients experience with peripheral IV cannulation when Buzzy® device is used versus when intradermal lidocaine 2% is used? The Numerical Rating Scale is used for linear measurement of satisfaction, where the minimum number is 1 (very dissatisfied) and the maximum number is 5 (very satisfied).
Time Frame
5-20 minutes
Title
Number of IV cannulation attempts
Description
How does first attempt during peripheral intravenous cannulation in adult patients compare when Buzzy® device is used versus when intradermal lidocaine 2% is used?
Time Frame
5-20 minutes
Title
Pain related to IV size based on the Visual Analog Scale
Description
Does size of the peripheral intravenous catheter affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Time Frame
5-20 minutes
Title
Pain related to IV location based on the Visual Analog Scale
Description
Does location of the peripheral intravenous catheter placement affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Time Frame
5-20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults ages 18 to 99
Non-pregnant women and men
Adults that are able to consent
Patients requiring intravenous catheter insertion for their operation/procedure
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Schoor, MD
Organizational Affiliation
physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Trial: Comparing Buzzy to Intradermal Lidocaine for Peripheral IV Cannulation in Adults
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