Distraction and Nitrous Oxide for Venous Puncture (DISPO)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety; Venous Puncture
• Intervention / Treatment: Other: Games on an iPad; Drug: Nitrous Oxide

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1206
    • Geneva Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Active Comparator: 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	Drug: Nitrous Oxide; Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Manon Cadoux, Student, University of Geneva; Principal Investigator: Virginie Luscher, Student, University of Geneva

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2018
• Primary Completion (Actual): May 21, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: December 1, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: nitrous oxide; distraction
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: in progress (Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No