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The effect of handheld-multimedia versus midazolam premedication on the level of perioperative anxiety in pediatric day-care. A randomized controlled trial.
EU CTIS ID: 2024-514642-37-00
What this study is testing
The goal of this study is, first, to evaluate the need for midazolampremedication in pediatric day-care patients induced by inhalational anesthesia, and second, to compare the efficacy and safety between anxiolysis by multimedia with an IPAD versus (no anxiolysis) and versus anxiolysis by premedication with midazolam prior to anestheticinduction. Our hypothesis is that Tablet/IPAD distraction could result in equal or better anxiety control in comparison to the standard care with midazolam-premedication. The primary endpoint is reduction in level of anxiety perioperative, primarily during induction in children between one and eight years of age in day-care-surgery.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 1 year and <8 years old
- ASA 1 or 2
- Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care
- Written informed consent by the legal parents or caretaker
You likely can't join if
- Parents of the patient wish not to participate with the study
- 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)
See the full eligibility criteria
- Age ≥ 1 year and <8 years old
- ASA 1 or 2
- Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care
- Written informed consent by the legal parents or caretaker
- Parents of the patient wish not to participate with the study
- 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)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.