Distraction and Nitrous Oxide for Venous Puncture

Not Applicable

Completed

• Conditions: Anxiety; Pain; Venous Puncture
• Interventions: Other: Games on an iPad; Drug: Nitrous Oxide

• Registration Number: NCT04185233
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-04-30
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-12-01
• Study First Posted: 2019-12-04
• Primary Completion: 2020-05-21
• Study Completion: 2020-09-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iPad distraction	Games on an iPad	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
Nitrous Oxide	Nitrous Oxide	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

Primary Outcome Measures

Name	Time	Method
Anxiety score	From one hour prior to venous puncture until 1 hour afterwards	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).

Secondary Outcome Measures

Name	Time	Method
Pain score	From one hour prior to venous puncture until 1 hour afterwards	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).

Trial Locations

Locations (1)

Geneva Children's Hospital; 🇨🇭 Geneva, Switzerland