Pilot Trial: Comparing Buzzy to Intradermal Lidocaine for Peripheral IV Cannulation in Adults

Pilot Randomized Control Trial: Comparing the Effectiveness of Buzzy Versus Intradermal Lidocaine for Peripheral Intravenous Cannulation in Adults

IV placement is necessary for surgical procedures. 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.

Study Overview

• Status: Withdrawn
• Conditions: Pain, Acute; Patient Satisfaction
• Intervention / Treatment: Drug: Lidocaine 2% Injectable Solution; Device: Buzzy

Detailed Description

Currently, some medical providers administer the IV without any pain-relieving techniques. Some medical providers inject a numbing medication underneath the skin prior to the IV placement. This requires an additional needle stick. 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 the injection of numbing medication underneath the skin for IV placement in adults. This device has been FDA approved for use.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • St. Elizabeth's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Adults ages 18 to 99
2. Non-pregnant women and men
3. Adults that are able to consent
4. Patients requiring intravenous catheter insertion for their operation/procedure

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intradermal Lidocaine 2%	Drug: Lidocaine 2% Injectable Solution; An elastic band will be placed around the subject's arm, and the elastic band will be removed once the IV is inserted. After the elastic band is placed on the subject's arm, the arm will be cleaned, and then a small skin wheel will be created with the lidocaine that will be injected very close to where the IV will be placed. The IV will be placed within about a minute from the time when the lidocaine was injected.
Experimental: Buzzy	Device: Buzzy; The Buzzy vibrating ice pack will be placed on the subject's arm with an elastic band around it, and it will remain there as the arm is cleaned and prepped and the IV inserted. The Buzzy device will be removed once the IV is inserted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain with IV Cannulation based on the Visual Analog Scale	How much pain do adult patients experience with peripheral IV cannulation when Buzzy® device is used versus when intradermal lidocaine 2% is used? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).	5-20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain related to IV location based on the Visual Analog Scale	Does location of the peripheral intravenous catheter placement affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).	5-20 minutes
Pain related to IV size based on the Visual Analog Scale	Does size of the peripheral intravenous catheter affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).	5-20 minutes
Satisfaction with IV cannulation based on the Numerical Rating Scale	How much satisfaction do adult patients experience with peripheral IV cannulation when Buzzy® device is used versus when intradermal lidocaine 2% is used? The Numerical Rating Scale is used for linear measurement of satisfaction, where the minimum number is 1 (very dissatisfied) and the maximum number is 5 (very satisfied).	5-20 minutes
Number of IV cannulation attempts	How does first attempt during peripheral intravenous cannulation in adult patients compare when Buzzy® device is used versus when intradermal lidocaine 2% is used?	5-20 minutes

Collaborators and Investigators

• Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Investigators: Principal Investigator: Michael Schoor, MD, Physician

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2022
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 21, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 00808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes