IVs With Buzzy in Chronic Pain Patients

Chronic Pain Clinical Trial

Official title:

IVs With Buzzy in Chronic Pain Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05555173
• Other study ID #: 00838
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 20, 2023

Study information

• Verified date: November 2023
• Source: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 20, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients receiving lidocaine infusions at the pain clinic. Exclusion Criteria: -

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
United States	St. Elizabeth's Medical Center	Boston	Massachusetts

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	through study completion, an average of 2 months