Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

Universitair Ziekenhuis Brussel

Status and phase: Unknown; Phase 4

Conditions: Ambulatory Surgery; Preanesthetic Medication; Circumcision; Tonsillectomy; Inhalation Anesthesia; Dental Care; Perioperative Anxiety

Treatments: Drug: Midazolam oral solution; Device: IPAD

Study type: Interventional

Funder types: Other

Identifiers

NCT04273035

2019-004671-39 (EudraCT Number)

2019/318

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 1 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Midazolam Group

Active Comparator group

Description:

* Midazolam(Buccolam 5mg/ml) * 0.5mg/kg oral, max 12mg * one time * given 30 min prior to going to holding

Treatment:

Drug: Midazolam oral solution

IPAD group

Active Comparator group

Description:

* No premedication * IPAD when arriving at the holding * any games, movies, clips, puzzles

Treatment:

Device: IPAD