Distraction and Nitrous Oxide for Venous Puncture (DISPO)

University Hospitals (UH)

Status: Completed

Conditions: Venous Puncture; Anxiety; Pain

Treatments: Drug: Nitrous Oxide; Other: Games on an iPad

Study type: Interventional

Funder types: Other

Identifiers

NCT04185233

in progress (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 patients

Sex: All

Ages: 3 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

iPad distraction

Experimental group

Description:

Children of this group will receive the iPad when the nurse will prepare the material for the venous track. They will choose a game adapted to their age and will be able to play it during all the procedure time. Intervention : game on iPad

Treatment:

Other: Games on an iPad

Nitrous Oxide

Active Comparator group

Description:

Children of this group will receive the Nitrous Oxide 3 minutes before the intervention (venous track). They will keep the mask during all the procedure time. Intervention : Nitrous Oxide

Treatment:

Drug: Nitrous Oxide