Observational Peripheral IV Insertion Study

NCT04762121 | Withdrawn

• 1 other identifier: EX070
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

IV placement is a common and necessary for surgical procedures. Unfortunately, pain associated with needle catheterization experienced during peripheral IV placement is a source anxiety and discomfort in many patients. The intensity of pain and distress caused by procedures can vary from mild to moderate, but also may be severe in certain patients resulting in numerous physiological, psychological, and emotional consequences. As such, the investigators ultimately aim to evaluate the techniques that could make the placement of the IV more comfortable.

Conditions

Pain, Acute; 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 with no pain relief method versus intradermal lidocaine 1% injection versus intradermal lidocaine 2% injection versus Buzzy® device? 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 (6)

• Satisfaction with IV cannulation based on the Numerical Rating Scale

  5-20 minutes

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

  5-20 minutes

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

  5-20 minutes

• Pain from IV insertion related to stage of the training of the healthcare provider based on the Visual Analog Scale

  5-20 minutes

• Pain from IV insertion based on the Visual Analog Scale related to history of patient having anxiety

  5-20 minutes

Study Arms (1)

Patients requiring intravenous catheter insertion

Adults (\>18 years old) who require intravenous catheter insertion for their operation/procedure

Procedure: Peripheral IV

Interventions

Peripheral IV PROCEDURE

Insertion of peripheral intravenous catheter

Patients requiring intravenous catheter insertion

Eligibility Criteria

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

Study Population

Patients requiring intravenous catheter insertion for their operation/procedure.

You may qualify if:

• Adults ages 18 to 99
• 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; Personal Satisfaction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: February 12, 2012
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)