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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iPad distraction | Experimental | 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 |
|
| Nitrous Oxide | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manon Cadoux, Student | University of Geneva, Switzerland | Principal Investigator |
| Virginie Luscher, Student | University of Geneva, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva Children's Hospital | Geneva | 1206 | Switzerland |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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Randomized clinical trial
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| Nitrous Oxide | Drug | Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one. |
|
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |