Status:
UNKNOWN
Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Perioperative Anxiety
Preanesthetic Medication
Eligibility:
All Genders
1-8 years
Phase:
PHASE4
Brief Summary
The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the induction. S...
Detailed Description
Perioperative anxiety in children is a common multifactorial influenced and triggered entity with an incidence as high as 50%. Especially (mask)induction of anesthesia is considered one of the most st...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age ≥ 1 year and \<8 years old
- ASA class 1 or 2 (American Society of Anesthesiologists Physical Status Classification System)
- Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care
- Written informed consent by the legal parents or caretaker
- Exclusion criteria
- Parents of the patient wish not to participate with the study
- Parents are not able to give informed consent (language barrier, legally incapable)
- A contraindication for the use of premedication with midazolam
- A known allergy to midazolam
- A contraindication for premedication in general
- A contraindication for the use of a gas-induction/gas-anesthesia
- A contraindication for the use of sevoflurane
- A known mental retardation of the child
- Preoperative behavioral disturbances and psychiatric disorders
- Any use of psychoactive medication
- A known photosensitive epilepsy
- A previous operation within 3 months of the time of scheduled operation
- Any other contraindication for the use of the study medication
- Previous history of multiple surgery (\>3)
Exclusion
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04273035
Start Date
February 1 2020
End Date
February 28 2022
Last Update
May 4 2021
Active Locations (1)
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1
Universitair Ziekenhuis Brussel (UZ Brussel)
Jette, Belgium, 1090