Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

NCT ID: NCT04273035

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2022-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Midazolam Group

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

Group Type: ACTIVE_COMPARATOR

Midazolam oral solution

Intervention Type: DRUG

Oral Buccolam

IPAD group

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

Group Type: ACTIVE_COMPARATOR

IPAD

Intervention Type: DEVICE

Playing any game, film, clip or puzzle on a tablet till after induction of anesthesia

Interventions

Midazolam oral solution

Oral Buccolam

Intervention Type: DRUG

IPAD

Playing any game, film, clip or puzzle on a tablet till after induction of anesthesia

Intervention Type: DEVICE

Other Intervention Names

Buccolam; Handheld multimedia, tablet

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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Van Hoorn, MD

Role: PRINCIPAL_INVESTIGATOR

Resident of department of Anesthesiology

Locations

Universitair Ziekenhuis Brussel (UZ Brussel)

Jette, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Alex Van Hoorn, MD

Role: CONTACT

Alex.VanHoorn@uzbrussel.be

+32468187852

Panagiotis Flamée, MD

Role: CONTACT

Panagiotis.Flamee@uzbrussel.be

+3224773143

Facility Contacts

Alex Van Hoorn, MD

Role: primary

Alex.VanHoorn@uzbrussel.be

+324749232

Pangiotis Flamée, MD

Role: backup

Panagiotis.Flamee@uzbrussel.be

+324773143

Other Identifiers

2019-004671-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2019/318

Identifier Type: -

Identifier Source: org_study_id