Distraction and Nitrous Oxide for Venous Puncture

University Hospital, Geneva45 enrolled

Overview

This study will compare the efficiency of the iPad distraction or the administration of Nitrous Oxide on the anxiety decrease when a peripheral venous catheter is needed in children between 3 and 9 years old.

The study is aiming at demonstrating the efficacy of active distraction by an iPad on the anxiety consequent to venipuncture and insertion of a peripheral vein catheter. The comparator is nitrous oxide in a 50% mixture with oxygen that is routinely used for sedation during procedural pain. However, nitrous oxide has secondary effects particularly on the inhibition of Vitamin B12. The primary outcome is anxiety scores. Secondary outcomes are pain scores and satisfaction of parents and health providers. All children will have EMLA cream (mixture prilocaine and lidocaine) applied one hour prior to venous punction. Anxiety, pain and satisfaction scores will be recorded at baseline and then within an hour following the venipuncture and insertion of the peripheral vein catheter.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Anxiety Pain Venous Puncture

Interventions

Games on an iPadOTHER

Many games will be programmed on the iPad and organized by age. The child will choose one game and play it during all the procedure time.

Nitrous OxideDRUG

Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Venous track needed * French mother tongue * Age between 3 and 9 years old Exclusion Criteria: * Children with cognitive disorder (autism, metabolic disorders, * Children with cerebral-motor disability * Children who don't speak french * Children with ADHD treatment * Children with epilepsy * Children who present contraindication to the use of Nitrous oxide

Locations (1)

Geneva Children's Hospital

Geneva, Switzerland

Outcomes

Primary Outcomes

Anxiety score

Anxiety level measured by a scale (modified Yale Preoperative Anxiety Scale) measured at baseline, during the venous puncture and one hour afterwards. The scale scores from a minimum of 5 (no anxiety) to 22 (extremely anxious).

Time frame: From one hour prior to venous puncture until 1 hour afterwards

Secondary Outcomes

Pain score

Pain intensity level will be measured at baseline, during the venous puncture and one hour afterwards, by a scale (Visual analog scale), which includes a score of 0 (no Pain) to 10 (worse pain).

Time frame: From one hour prior to venous puncture until 1 hour afterwards

Data from ClinicalTrials.gov

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