Distraction and Nitrous Oxide for Venous Puncture

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anxiety, Pain, Venous Puncture

Intervention / Treatment
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* Other: Games on an iPad
* Drug: Nitrous Oxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iPad distraction<br>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<br>* 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.<br>|
| Active Comparator: Nitrous Oxide<br>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<br>* Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nitrous oxide, distraction