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Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

Recruiting
1-8 years
All
Phase 4

Overview

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.

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 stressful experiences for a child undergoing surgery. A common practice worldwide to diminish the level of anxiety prior to anesthesia is premedication with the benzodiazepine midazolam in order to improve cooperation during induction.

Premedication with midazolam has a primary purpose to reduce preoperative anxiety and has inherent to a benzodiazepine its sedative effects. Although these effects are implied, negative effects of premedication: respiratory complications, paradoxical negative behavior has been reported. Although alternative medications have been studied, studies for non-pharmacological anxiety-reduction remain limited.

Non-pharmacological anxiety-reduction by distraction including Tablet or IPAD-multimedia might be a readily available alternative for midazolam premedication. Potentially limiting the use of psychoactive agents, limiting the need for preoperative sedation and therefore possibly decrease secondary respiratory complications in pediatric surgical day-care.

Objective

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

Eligibility

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)

Study details
    Tonsillectomy
    Circumcision
    Ambulatory Surgery
    Dental Care
    Preanesthetic Medication
    inhalation anesthesia
    Perioperative Anxiety

NCT04273035

Universitair Ziekenhuis Brussel

16 February 2024

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