Distraction and Nitrous Oxide for Venous Puncture

Pain Clinical Trial

— DISPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185233
• Other study ID #: in progress
• Status: Completed
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 30, 2020
• Est. primary completion date: May 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Venous Puncture

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Geneva Children's Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction score	Satisfaction of parents and care givers about the cares given to the child using a rating scale from 1(not satisfied at all) to 10 (extremely satisfied).	From time of venous puncture until 1 hour afterwards
Primary	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).	From one hour prior to venous puncture until 1 hour afterwards
Secondary	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).	From one hour prior to venous puncture until 1 hour afterwards