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IVs With Buzzy in Chronic Pain Patients

NCT ID: NCT05555173

Last Updated: 2023-12-01

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-10-20

Brief Summary

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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

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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.

Conditions

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Chronic Pain Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Buzzy

Intervention Type DEVICE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Buzzy

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients receiving lidocaine infusions at the pain clinic.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic Gerges, MD

Role: PRINCIPAL_INVESTIGATOR

Pain Medicine Physician

Locations

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St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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00838

Identifier Type: -

Identifier Source: org_study_id