Peripheral Intravenous Catheter Bundle

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07249255

Acronym

deu-acil-bd

Enrollment

800

Registered

2025-11-25

Start date

2024-02-01

Completion date

2025-02-01

Last updated

2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter, Catheter Complications, Pediatric

Brief summary

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.

Detailed description

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.

Interventions

DEVICEVein Imaging Device

Vein Imaging Device before PIVC insertion

DEVICEVialon catheters

Vialon catheter use for PIVC insertion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 6 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
PIVC indwelling time	immediately after the PIC intervention	PIVC stay time
PIVC insertion related pain score	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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026