IVs With Buzzy in Chronic Pain Patients
Primary Purpose
Chronic Pain, Acute Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Buzzy
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Patients receiving lidocaine infusions at the pain clinic.
Exclusion Criteria:
-
Sites / Locations
- St. Elizabeth's Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Buzzy
No Buzzy
Arm Description
Buzzy will be applied 5 to 10 cm proximal (toward the subject's head) to the dorsum of the hand site immediately prior and throughout the intravenous catheter insertion attempt.
Subjects will have a 20g intravenous catheter inserted either in the left or right dorsum side of the hand without the Buzzy device.
Outcomes
Primary Outcome Measures
Pain on the Numeric Rating Scale
Patients are asked to report their subjective pain on the Numeric Rating Scale from 0 to 10, where 0 = No Pain and 10 = Worst Pain.
Secondary Outcome Measures
Satisfaction on the Visual Analog Scale
Patients are asked to report their subjective satisfaction with the IV placement on the Visual Analog Scale, where labeled face images represent satisfaction from very poor satisfaction to excellent satisfaction.
Full Information
NCT ID
NCT05555173
First Posted
September 16, 2022
Last Updated
December 14, 2022
Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05555173
Brief Title
IVs With Buzzy in Chronic Pain Patients
Official Title
IVs With Buzzy in Chronic Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The investigators are conducting a study to compare the effectiveness of the Buzzy® device with that of no pain relief method for IV placement in adults with chronic pain receiving lidocaine infusions.
Detailed Description
IV placement is necessary for lidocaine infusions. 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. Currently, some medical providers administer the IV without any pain-relieving techniques. 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 no pain relief method for IV placement in adults with chronic pain receiving lidocaine infusions. The use of the Buzzy® device in adults is the investigational part of the study. 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
Chronic Pain, Acute Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Buzzy
Arm Type
Experimental
Arm Description
Buzzy will be applied 5 to 10 cm proximal (toward the subject's head) to the dorsum of the hand site immediately prior and throughout the intravenous catheter insertion attempt.
Arm Title
No Buzzy
Arm Type
No Intervention
Arm Description
Subjects will have a 20g intravenous catheter inserted either in the left or right dorsum side of the hand without the Buzzy device.
Intervention Type
Device
Intervention Name(s)
Buzzy
Intervention Description
Buzzy is a small vibrating bee with ice-pack wings.
Primary Outcome Measure Information:
Title
Pain on the Numeric Rating Scale
Description
Patients are asked to report their subjective pain on the Numeric Rating Scale from 0 to 10, where 0 = No Pain and 10 = Worst Pain.
Time Frame
through study completion, an average of 2 months
Secondary Outcome Measure Information:
Title
Satisfaction on the Visual Analog Scale
Description
Patients are asked to report their subjective satisfaction with the IV placement on the Visual Analog Scale, where labeled face images represent satisfaction from very poor satisfaction to excellent satisfaction.
Time Frame
through study completion, an average of 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients receiving lidocaine infusions at the pain clinic.
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Levin, MD
Phone
(617) 789-2804
Email
Danielle.Levin@steward.org
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Acquadro, MD, DMD
Phone
(617) 789-2804
Email
Martin.Acquadro@steward.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic Gerges, MD
Organizational Affiliation
Pain Medicine Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
IVs With Buzzy in Chronic Pain Patients
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