Anxiety, Pain, Venous Puncture
Conditions
Keywords
nitrous oxide, distraction
Brief 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.
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.
Interventions
OTHERGames 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.
DRUGNitrous Oxide
Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety score | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 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
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction score | 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). |
Countries
Switzerland
Outcome results
None listed