NCT05555173

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

September 16, 2022

Last Update Submit

February 23, 2026

Conditions

Chronic PainAcute Pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 2 months

Secondary Outcomes (1)

  • Satisfaction on the Visual Analog Scale

    through study completion, an average of 2 months

Study Arms (2)

Buzzy

EXPERIMENTAL

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

No Buzzy

NO INTERVENTION

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

Interventions

BuzzyDEVICE

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

Buzzy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving lidocaine infusions at the pain clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Chronic PainAcute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frederic Gerges, MD

    Pain Medicine Physician

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 26, 2022

Study Start

October 1, 2022

Primary Completion

October 20, 2023

Study Completion

October 20, 2023

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)