Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

The Effect of Handheld-multimedia Versus Oral Midazolam Preanesthetic on the Level of Perioperative Anxiety in Pediatric Day-care Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Tonsillectomy; Preanesthetic Medication; Circumcision; Ambulatory Surgery; Inhalation Anesthesia; Dental Care; Perioperative Anxiety
• Intervention / Treatment: Drug: Midazolam oral solution; Device: IPAD

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alex Van Hoorn, MD; Phone Number: +32468187852; Email: Alex.VanHoorn@uzbrussel.be
• Study Contact Backup: Name: Panagiotis Flamée, MD; Phone Number: +3224773143; Email: Panagiotis.Flamee@uzbrussel.be

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel (UZ Brussel)
    • Contact: Alex Van Hoorn, MD; Phone Number: +324749232; Email: Alex.VanHoorn@uzbrussel.be
    • Contact: Pangiotis Flamée, MD; Phone Number: +324773143; Email: Panagiotis.Flamee@uzbrussel.be
    • Principal Investigator: Alex Van Hoorn, MD
    • Principal Investigator: Pangiotis Flamée, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Midazolam Group; Midazolam(Buccolam 5mg/ml); 0.5mg/kg oral, max 12mg; one time; given 30 min prior to going to holding	Drug: Midazolam oral solution; Oral Buccolam; Other Names: Buccolam
Active Comparator: IPAD group; No premedication; IPAD when arriving at the holding; any games, movies, clips, puzzles	Device: IPAD; Playing any game, film, clip or puzzle on a tablet till after induction of anesthesia; Other Names: Handheld multimedia, tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety level at Daycare	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 at Daycare (T0) when leaving to holding	Leaving daycare, 10 minutes
Anxiety level at holding	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 at holding (T1) 10 minutes after arrival	On holding, 20 minutes
Anxiety level at recovery	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 at recovery (T3) 15 minutes after awake	15 minutes after awake, 30 minutes
Anxiety level Change Daycare vs OR	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/4 * 100 and therefore a score between 23,3-100	change during daycare (T0) and induction(T2) in the OR, average 1 hour
Sedation level at Daycare	Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at Daycare (T0) when leaving to holding	10 minutes
Sedation level at holding	Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored (T1) 10 minutes after arrival holding	20 minutes
Sedation level at induction	Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at moment of mask induction (T2)	10 minutes
Sedation level at recovery	Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored 15 minutes after arrival recovery (T3)	30 minutes
Laryngospasm at induction	Laryngospasm by Four-point scale: No Laryngospasm; Mild laryngospasm (relieved by jaw thrust and 100% oxygen),; Moderate laryngospasm (relieved by 100% oxygen and positive pressure ventilation); Severe laryngospasm (relieved by succinylcholine and intubation) Scored in the OR post-induction	10 minutes
Laryngospasm post extubation/post laryngeal mask	Laryngospasm by Four-point scale: No Laryngospasm; Mild laryngospasm (relieved by jaw thrust and 100% oxygen),; Moderate laryngospasm (relieved by 100% oxygen and positive pressure ventilation); Severe laryngospasm (relieved by succinylcholine and intubation) Scored in the OR post detubation/post laryngeal mask	10 minutes
Bronchospasm postinduction	Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR postinduction	10 minutes
Bronchospasm post detubation/laryngeal mask	Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR post detonation/laryngeal mask	10 minutes
Postoperative Pain	The pain observation scale for young children (POCIS-Score) score 0-7, scoring 0 or1 for • face-expression: frowning/grimaces = 1, sound crying/moan =1, breathing: irregular/gasping/holding=1, body tonus: tense/shiver/restless =1, movement of arms: tense/fist/restless =1, movement of legs: tense/pulled up/flexed = 1, mood: agitation/restless = 1 Scored on the recovery 30 minutes after arrival	40 minutes
Parental Satisfaction on the anxiety-management at daycare	Very satisfied; Satisfied; Neutral; Unsatisfactory; Very Unsatisfactory Scored at daycare-surgery (T0)	10 minutes
Parental Satisfaction on the anxiety-management at holding	Very satisfied; Satisfied; Neutral; Unsatisfactory; Very Unsatisfactory Scored at holding (T1)	10 minutes
Parental Satisfaction on the anxiety-management at OR	Very satisfied; Satisfied; Neutral; Unsatisfactory; Very Unsatisfactory Scored after induction and parent has left the OR (T2)	10 minutes
Parental Satisfaction on the anxiety-management at recovery	Very satisfied; Satisfied; Neutral; Unsatisfactory; Very Unsatisfactory Scored at the recovery (T3)	10 minutes
Parental Stress level at day care	Parental Stress level in 5 - point scale- ´I feel': Extremely Stressed; Very stressed; moderate stressed; Low stressed; Very low stressed scored at day care (T0)	10 minutes
Parental Stress level at holding	Parental Stress level in 5 - point scale- ´I feel': Extremely Stressed; Very stressed; moderate stressed; Low stressed; Very low stressed Scored at holding (T1)	10 minutes
Parental Stress level at OR	Parental Stress level in 5 - point scale- ´I feel': Extremely Stressed; Very stressed; moderate stressed; Low stressed; Very low stressed Scored at OR (T2)	10 minutes
Parental Stress level at recovery	Parental Stress level in 5 - point scale- ´I feel': Extremely Stressed; Very stressed; moderate stressed; Low stressed; Very low stressed Scored at recovery (T3)	10 minutes
Overall Parental Satisfaction	5- Point scale; Very satisfied; Satisfied; Neutral; Unsatisfactory; Very Unsatisfactory Scored when leaving recovery	10 minutes
Child Stress level by parent at daycare	Child Stress level by parent, 5- Point scale; Happy, plays; Slightly worried; Worried, stops playing; Fears, crying; Hysterical Scored at daycare-surgery (T0)	10 minutes
Child Stress level by parent at holding	Child Stress level by parent, 5- Point scale; Happy, plays; Slightly worried; Worried, stops playing; Fears, crying; Hysterical Scored at holding (T1)	10 minutes
Child Stress level by parent at OR	Child Stress level by parent, 5- Point scale; happy, plays; slightly worried; worried, stops playing; fear, crying; hysterical Scored at OR after induction (T2)	10 minutes
Child Stress level by parent at Recovery	Child Stress level by parent, 5- Point scale; Happy, plays; Slightly worried; Worried, stops playing; Fear, crying; Hysterical Scored at recovery (T3)	10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative need for pain medication	Postoperative need for pain medication, indicated as yes or no, and description of medication with given dose Noted on the recovery	1 hour
Postoperative need for anti-nausea/vomiting medication	Postoperative need for anti-nausea/vomiting medication, indicated as yes or no, and description of product with given dose Noted on the recovery	1 hour
Time arrival recovery to time leaving recovery	Time arrival recovery to time leaving recovery, time notation on arrival and leaving Noted on the recovery	2 hour

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Alex Van Hoorn, MD, Resident of department of Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Anxiety; Midazolam; Multimedia; Preanesthetic medication; Handheld computer; Mask induction; Day Care Surgery
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 2019/318; 2019-004671-39 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data will be available after deidentification; For researchers who provide a methodological proposal; Achieving aims in the proposal; Proposals needs to be directed to the principal investigators
• IPD Sharing Time Frame: Available 3 months after study publication for 10 years
• IPD Sharing Access Criteria: Written request and providing a methodological proposal
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No