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Completed

NCT Number: NCT07182994

Immobilization During Peripheral Venous Catheter Placement

Aim: To determine the most effective type of upper limb immobilization in the cannulation of a peripheral venous line in the pediatric emergency department.

Methods: Randomized clinical trial with 322 patients conducted in a tertiary pediatric emergency. The impact of two types of restraints (immobilization of the elbow joint versus arm restraint, without immobilization of the elbow joint) on the success of the technique was analyzed. Multivariate analysis was used to analyze the impact of other variables (weight, age, movements, pain) on the success of the technique.

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Key information

Conditions

Pediatrics Immobilization

Age range

1 day–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario La Paz

Madrid, 28022, Spain

About this study

A study will be conducted in a Spanish tertiary hospital to assess the holding technique for peripheral venous catheterization in pediatric patients presenting to the pediatric emergency department. The nursing staff will be responsible for implementing the study protocol, data collection, and subsequent analysis.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pediatric patients at emergency department that need a peripheral venous line

Exclusion criteria

  • Critically ill patient

Treatment and study plan

Elbow joint immobilization

Procedure

Immobilization of the elbow joint during peripheral venous line cannulation in pediatric patients on the success of the technique

Arm restraint without elbow immobilization

Procedure

Use of arm restraint without immobilization of the elbow joint during peripheral venous line cannulation in pediatric patients.

Primary outcomes

  1. success of peripheral venous line cannulation on the first attempt

    Time frame: From enrollment to the end of the procedure (15 minutes)

    Percentage of successful cannulations on the first attempt, as assessed by the registered nurse.

Secondary outcomes

  1. Number of attempts required

    Time frame: From enrollment to the end of the procedure (15 minutes)

    Number of cannulation attempts until successful catheterization.

  2. Time to successful catheterization

    Time frame: From start of procedure until catheter placement (≤15 minutes)

    Time in minutes from first attempt to successful catheter placement

  3. Nurse's assessment of patient's pain

    Time frame: Immediately after procedure

    Pain assessed by the nurse using a validated age-appropriate pediatric pain scale

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Official study title

Immobilization During Peripheral Venous Catheter Placement in Paediatric Emergency Care: a Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2025
Registry last updated
Sep 19, 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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