Distraction and Nitrous Oxide for Venous Puncture

NCT ID: NCT04185233

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2020-09-30

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.

Conditions

Anxiety; Pain; Venous Puncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

iPad distraction

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

Group Type: EXPERIMENTAL

Games on an iPad

Intervention Type: OTHER

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 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

Group Type: ACTIVE_COMPARATOR

Nitrous Oxide

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: OTHER

Nitrous Oxide

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Walid HABRE

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manon Cadoux, Student

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Virginie Luscher, Student

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Locations

Geneva Children's Hospital

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

in progress

Identifier Type: -

Identifier Source: org_study_id