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

NCT04647084 | Withdrawn Phase 4 FDA Drug FDA Device

• 1 other identifier: 00808
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Satisfaction with IV cannulation based on the Numerical Rating Scale

  5-20 minutes

• Number of IV cannulation attempts

  5-20 minutes

• Pain related to IV size based on the Visual Analog Scale

  5-20 minutes

• Pain related to IV location based on the Visual Analog Scale

  5-20 minutes

Study Arms (2)

Intradermal Lidocaine 2%

EXPERIMENTAL

Drug: Lidocaine 2% Injectable Solution

Buzzy

EXPERIMENTAL

Device: Buzzy

Interventions

Lidocaine 2% Injectable Solution DRUG

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.

Intradermal Lidocaine 2%

Buzzy DEVICE

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.

Buzzy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Acute Pain; Patient Satisfaction

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michael Schoor, MD

  physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 30, 2020
• Study Start: October 15, 2022
• Primary Completion: October 15, 2024
• Study Completion: May 31, 2025
• Last Updated: August 18, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)