Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

NCT04273035 | Unknown Phase 4 DMC

• 2 other identifiers: 2019/3182019-004671-39
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Anxiety level at induction

  Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/5 \* 100 and therefore a score between 23,3-100 Scored prior moment of mask induction (T2)

  Directly prior to induction of anesthesia, 20 minutes

• Anesthesiologist Satisfaction Induction

  Satisfactory Score for Induction/Anesthesia: 5 point scale: Very satisfactory, Satisfactory, Neutral, Unsatisfactory and Very satisfactory Scored in the OR directly post induction

  During induction of anesthesia 10 minutes

Secondary Outcomes (26)

• Anxiety level at Daycare

  Leaving daycare, 10 minutes

• Anxiety level at holding

  On holding, 20 minutes

• Anxiety level at recovery

  15 minutes after awake, 30 minutes

• Anxiety level Change Daycare vs OR

  change during daycare (T0) and induction(T2) in the OR, average 1 hour

• Sedation level at Daycare

  10 minutes

Other Outcomes (3)

• Postoperative need for pain medication

  1 hour

• Postoperative need for anti-nausea/vomiting medication

  1 hour

• Time arrival recovery to time leaving recovery

  2 hour

Study Arms (2)

Midazolam Group

ACTIVE COMPARATOR

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

Drug: Midazolam oral solution

IPAD group

ACTIVE COMPARATOR

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

Device: IPAD

Interventions

Midazolam oral solution DRUG

Oral Buccolam

Also known as: Buccolam

Midazolam Group

IPAD DEVICE

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

Also known as: Handheld multimedia, tablet

IPAD group

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel (UZ Brussel)

Jette, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alex Van Hoorn, MD

  Resident of department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Van Hoorn, MD

CONTACT

+32468187852; Alex.VanHoorn@uzbrussel.be

Panagiotis Flamée, MD

CONTACT

+3224773143; Panagiotis.Flamee@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: digital block randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A: midazolam premedicated, standard of care Group B: IPAD, no midazolam premedication

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 17, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: February 28, 2022
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available 3 months after study publication for 10 years
• Access Criteria: Written request and providing a methodological proposal

Locations

BE (1)