IVs With Buzzy in Chronic Pain Patients

Not Applicable

Terminated

• Conditions: Acute Pain; Chronic Pain
• Interventions: Device: Buzzy

• Registration Number: NCT05555173
• Lead Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.

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.

Study Timeline

• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-26
• Study Start: 2022-10-01
• Primary Completion: 2023-10-20
• Study Completion: 2023-10-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients receiving lidocaine infusions at the pain clinic.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Buzzy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

St. Elizabeth's Medical Center; 🇺🇸 Boston, Massachusetts, United States