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Completed

NCT Number: NCT07249255

Peripheral Intravenous Catheter Bundle

The study was designed to investigate the effects of a PIVC Bundle, which includes a vein visualization device and a vial (BD Neoflon™ Pro catheter), on catheter placement success, complications, procedure-related pain, and catheter length of stay in children aged 1-6 years who are scheduled for peripheral intravenous catheter (PIVC) insertion.

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Key information

Conditions

Pediatric Catheter Catheter Complications

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, 35100, Turkey (Türkiye)

About this study

The study sample included four groups: (1) vein visualization device (VGC) and Vialon Catheter Group, (2) VGC and Standard/Teflon Catheter Group, (3) Vialon Catheter Group, (4) Standard/Teflon Catheter Group/Control Group. Data were collected using the Socio-Demographic Data Collection Form, the Forced Intravenous Intervention Score, the PIVC Site Follow-up Form, the Infiltration Scale, the Extravasation Scale, the Phlebitis Scale, and the FLACC Pain Diagnosis Scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • must be between 1 and 6 years old.
  • must be inserted PIC

Exclusion criteria

  • must be shock or severe dehydration, unconsciousness.
  • had a central catheter.
  • must be inserted at the lower extremities.

Treatment and study plan

Vein Imaging Device

Device

Vein Imaging Device before PIVC insertion

Vialon catheters

Device

Vialon catheter use for PIVC insertion

Primary outcomes

  1. PIVC insertion related pain score

    Time frame: FLACC score evaluated 3 minutes after the PIVC insertion

    The FLACC (Face, Legs, Activity, Cry, Consolability) score related to the PIVC insertion. The scale is scored in a range of 0-10, with 0 representing no pain. Assessment of score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain

  2. PIVC indwelling time

    Time frame: immediately after the PIC intervention

    PIVC stay time

Sponsors and collaborators

Lead sponsor

Gülçin Özalp Gerçeker

Other

Registry information

Official study title

The Effect of Peripheral Intravenous Catheter Bundle on Catheter Insertion Success, Complication Development, and Procedure-Related Pain in Patients Presenting to the Pediatric Emergency Department

Acronym: deu-acil-bd

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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