Clinical trial NCT04273035: Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety
Official title: The Effect of Handheld-multimedia Versus Oral Midazolam Preanesthetic on the Level of Perioperative Anxiety in Pediatric Day-care Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Perioperative Anxiety
Preanesthetic Medication
Inhalation Anesthesia
Ambulatory Surgery
Tonsillectomy
Circumcision
Dental Care
Keywords: Preanesthetic medication
Handheld computer
Midazolam
Multimedia
Anxiety
Mask induction
Day Care Surgery
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: midazolam premedicated, standard of care Group B: IPAD, no midazolam premedication
Primary purpose: TREATMENT

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

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 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 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)

Primary outcomes:
measure: Anxiety level at induction
timeFrame: Directly prior to induction of anesthesia, 20 minutes
measure: Anesthesiologist Satisfaction Induction
timeFrame: During induction of anesthesia 10 minutes
Secondary outcomes:
measure: Anxiety level at Daycare
timeFrame: Leaving daycare, 10 minutes
measure: Anxiety level at holding
timeFrame: On holding, 20 minutes
measure: Anxiety level at recovery
timeFrame: 15 minutes after awake, 30 minutes
measure: Anxiety level Change Daycare vs OR
timeFrame: change during daycare (T0) and induction(T2) in the OR, average 1 hour
measure: Sedation level at Daycare
timeFrame: 10 minutes
measure: Sedation level at holding
timeFrame: 20 minutes
measure: Sedation level at induction
timeFrame: 10 minutes
measure: Sedation level at recovery
timeFrame: 30 minutes
measure: Laryngospasm at induction
timeFrame: 10 minutes
measure: Laryngospasm post extubation/post laryngeal mask
timeFrame: 10 minutes
measure: Bronchospasm postinduction
timeFrame: 10 minutes
measure: Bronchospasm post detubation/laryngeal mask
timeFrame: 10 minutes
measure: Postoperative Pain
timeFrame: 40 minutes
measure: Parental Satisfaction on the anxiety-management at daycare
timeFrame: 10 minutes
measure: Parental Satisfaction on the anxiety-management at holding
timeFrame: 10 minutes
measure: Parental Satisfaction on the anxiety-management at OR
timeFrame: 10 minutes
measure: Parental Satisfaction on the anxiety-management at recovery
timeFrame: 10 minutes
measure: Parental Stress level at day care
timeFrame: 10 minutes
measure: Parental Stress level at holding
timeFrame: 10 minutes
measure: Parental Stress level at OR
timeFrame: 10 minutes
measure: Parental Stress level at recovery
timeFrame: 10 minutes
measure: Overall Parental Satisfaction
timeFrame: 10 minutes
measure: Child Stress level by parent at daycare
timeFrame: 10 minutes
measure: Child Stress level by parent at holding
timeFrame: 10 minutes
measure: Child Stress level by parent at OR
timeFrame: 10 minutes
measure: Child Stress level by parent at Recovery
timeFrame: 10 minutes
Other outcomes:
measure: Postoperative need for pain medication
timeFrame: 1 hour
measure: Postoperative need for anti-nausea/vomiting medication
timeFrame: 1 hour
measure: Time arrival recovery to time leaving recovery
timeFrame: 2 hour
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel (UZ Brussel)
Study officials:
affiliation: Resident of department of Anesthesiology
name: Alex Van Hoorn, MD
role: PRINCIPAL_INVESTIGATOR
References: