Immobilization During Peripheral Venous Catheter Placement

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatrics; Immobilization
• Intervention / Treatment: Procedure: Elbow joint immobilization; Procedure: Arm restraint without elbow immobilization

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 322
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28022
      • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Critically ill patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: elbow joint immobilization; Pediatric patients undergo cannulation of a peripheral venous line with immobilization of the elbow joint	Procedure: Elbow joint immobilization; Immobilization of the elbow joint during peripheral venous line cannulation in pediatric patients on the success of the technique
Active Comparator: arm restraint without immobilization of the elbow joint; Pediatric patients undergo cannulation of a peripheral venous line with arm restraint, but the elbow joint is not immobilized.	Procedure: Arm restraint without elbow immobilization; Use of arm restraint without immobilization of the elbow joint during peripheral venous line cannulation in pediatric patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success of peripheral venous line cannulation on the first attempt	Percentage of successful cannulations on the first attempt, as assessed by the registered nurse.	From enrollment to the end of the procedure (15 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempts required	Number of cannulation attempts until successful catheterization.	From enrollment to the end of the procedure (15 minutes)
Time to successful catheterization	Time in minutes from first attempt to successful catheter placement	From start of procedure until catheter placement (≤15 minutes)
Nurse's assessment of patient's pain	Pain assessed by the nurse using a validated age-appropriate pediatric pain scale	Immediately after procedure

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: August 29, 2025
• First Submitted That Met QC Criteria: September 13, 2025
• First Posted (Estimated): September 19, 2025

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 13, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: pediatrics; immobilization; catheter; emergency medical services; nurses, pediatric
• Other Study ID Numbers: Immobilization catheter

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the study involves a small sample of pediatric patients in a single hospital. Sharing the data could compromise confidentiality despite de-identification, and the main outcomes will be disseminated through peer-reviewed publications and conference presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No