Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

Tonsillectomy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04273035
• Other study ID #: 2019/318
• Secondary ID: 2019-004671-39
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: Alex Van Hoorn, MD
• Phone: +32468187852
• Email: Alex.VanHoorn[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Midazolam oral solution
Oral Buccolam

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

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel (UZ Brussel)	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Sedation level at Daycare	Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at Daycare (T0) when leaving to holding	10 minutes
Secondary	Sedation level at holding	Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored (T1) 10 minutes after arrival holding	20 minutes
Secondary	Sedation level at induction	Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at moment of mask induction (T2)	10 minutes
Secondary	Sedation level at recovery	Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored 15 minutes after arrival recovery (T3)	30 minutes
Secondary	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
Secondary	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
Secondary	Bronchospasm postinduction	Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR postinduction	10 minutes
Secondary	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
Secondary	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
Secondary	Parental Satisfaction on the anxiety-management at daycare	Very satisfied; Satisfied; Neutral; Unsatisfactory; Very Unsatisfactory Scored at daycare-surgery (T0)	10 minutes
Secondary	Parental Satisfaction on the anxiety-management at holding	Very satisfied; Satisfied; Neutral; Unsatisfactory; Very Unsatisfactory Scored at holding (T1)	10 minutes
Secondary	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
Secondary	Parental Satisfaction on the anxiety-management at recovery	Very satisfied; Satisfied; Neutral; Unsatisfactory; Very Unsatisfactory Scored at the recovery (T3)	10 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall Parental Satisfaction	5- Point scale; Very satisfied; Satisfied; Neutral; Unsatisfactory; Very Unsatisfactory Scored when leaving recovery	10 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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