IVs With Buzzy in Chronic Pain Patients

Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT05555173
Collaborator
(none)
100
1
2
12
8.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Buzzy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
IVs With Buzzy in Chronic Pain Patients
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Buzzy

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.

Device: Buzzy
Buzzy is a small vibrating bee with ice-pack wings.

No Intervention: No Buzzy

Subjects will have a 20g intravenous catheter inserted either in the left or right dorsum side of the hand without the Buzzy device.

Outcome Measures

Primary Outcome Measures

  1. Pain on the Numeric Rating Scale [through study completion, an average of 2 months]

    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

  1. Satisfaction on the Visual Analog Scale [through study completion, an average of 2 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients receiving lidocaine infusions at the pain clinic.
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Elizabeth's Medical Center Boston Massachusetts United States 02135

Sponsors and Collaborators

  • Steward St. Elizabeth's Medical Center of Boston, Inc.

Investigators

  • Principal Investigator: Frederic Gerges, MD, Pain Medicine Physician

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:
NCT05555173
Other Study ID Numbers:
  • 00838
First Posted:
Sep 26, 2022
Last Update Posted:
Dec 19, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 19, 2022