Status:
COMPLETED
Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Paediatric Outpatient Surgery
Eligibility:
All Genders
4-10 years
Phase:
PHASE3
Brief Summary
Rationale: The most frequently used means to prevent pre-anaesthetic anxiety in children is a drug premedication. Midazolam, a benzodiazepine, is mainly used. It requires time for action, so coordina...
Eligibility Criteria
Inclusion
- Girls and boys aged 4 to 10 years,
- American Society of Anesthesiologists Score between 1 and 3,
- programmed outpatient surgery for a short term and low level of pain
- Infection with influenza A virus confirmed with a quick diagnostic test,
- informed consent from both parents
Exclusion
- patients younger than 4 or older than 10 years old
- preexisting psychiatric disorder with pedo-psychiatric follow-up
- children with intellectual disability
- psychotropic referred to anxiolytic and / or antipsychotic
- history of surgery (n\>=3)
- refusal to participate
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT02192710
Start Date
May 1 2013
End Date
April 1 2014
Last Update
December 19 2025
Active Locations (1)
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1
Service d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, France, 69500