NCT04185233

Distraction and Nitrous Oxide for Venous Puncture

Comparison in Anxiety and Pain Scores Between Distraction and Nitrous Oxide for Procedural Pain in Children Aged 3 to 9 Years : a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 3 Years – 9 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anxiety
• Pain
• Venous Puncture

Interventions

Type	Name	Description
OTHER	Games on an iPad	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.
DRUG	Nitrous Oxide	Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.

Timeline

• Start date: 2018-04-30
• Primary completion: 2020-05-21
• Completion: 2020-09-30
• First posted: 2019-12-04
• Last updated: 2021-01-06

Locations

1 site across 1 country: Switzerland