Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

Last updated: May 3, 2021
Sponsor: Universitair Ziekenhuis Brussel
Overall Status: Active - Recruiting

Phase

4

Condition

Panic Disorders

Mood Disorders

Anxiety Disorders

Treatment

N/A

Clinical Study ID

NCT04273035
2019/318
2019-004671-39
  • Ages 1-8
  • All Genders

Study 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.

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)

Study Design

Total Participants: 150
Study Start date:
February 01, 2020
Estimated Completion Date:
February 28, 2022

Study 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.

Connect with a study center

  • Universitair Ziekenhuis Brussel (UZ Brussel)

    Jette, 1090
    Belgium

    Active - Recruiting

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