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Completed

NCT Number: NCT04185233

Distraction and Nitrous Oxide for Venous Puncture

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Venous Puncture

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva Children's Hospital

Geneva, 1206, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Games on an iPad

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

Drug

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

Primary outcomes

  1. Anxiety score

    Time frame: 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 outcomes

  1. Pain score

    Time frame: 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).

Other outcomes

  1. Satisfaction score

    Time frame: From time of venous puncture until 1 hour afterwards

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study 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

Acronym: DISPO

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2019
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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