Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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. Secondly to evaluate the need for midazolam-premedication in pediatric day-care patients induced by inhalational anesthesia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitair Ziekenhuis Brussel
• Treatments: Midazolam

Criteria

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)