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.

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.

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

Preanesthetic medication, Handheld computer, Midazolam, Multimedia, Anxiety, Mask induction, Day Care Surgery

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)

Satisfactory Score for Induction/Anesthesia: 5 point scale: Very satisfactory, Satisfactory, Neutral, Unsatisfactory and Very satisfactory Scored in the OR directly post 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 at Daycare (T0) when leaving to 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

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

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

Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at Daycare (T0) when leaving to holding

Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored (T1) 10 minutes after arrival holding

Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at moment of mask induction (T2)

Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored 15 minutes after arrival recovery (T3)

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

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

Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR post detonation/laryngeal mask

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

Very satisfied Satisfied Neutral Unsatisfactory Very Unsatisfactory Scored after induction and parent has left the OR (T2)

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)

Parental Stress level in 5 - point scale- ´I feel': Extremely Stressed Very stressed moderate stressed Low stressed Very low stressed Scored at holding (T1)

Parental Stress level in 5 - point scale- ´I feel': Extremely Stressed Very stressed moderate stressed Low stressed Very low stressed Scored at OR (T2)

Parental Stress level in 5 - point scale- ´I feel': Extremely Stressed Very stressed moderate stressed Low stressed Very low stressed Scored at recovery (T3)

5- Point scale Very satisfied Satisfied Neutral Unsatisfactory Very Unsatisfactory Scored when leaving recovery

Child Stress level by parent, 5- Point scale Happy, plays Slightly worried Worried, stops playing Fears, crying Hysterical Scored at daycare-surgery (T0)

Child Stress level by parent, 5- Point scale Happy, plays Slightly worried Worried, stops playing Fears, crying Hysterical Scored at holding (T1)

Child Stress level by parent, 5- Point scale happy, plays slightly worried worried, stops playing fear, crying hysterical Scored at OR after induction (T2)

Child Stress level by parent, 5- Point scale Happy, plays Slightly worried Worried, stops playing Fear, crying Hysterical Scored at recovery (T3)

Postoperative need for pain medication, indicated as yes or no, and description of medication with given dose Noted on the recovery

Postoperative need for anti-nausea/vomiting medication, indicated as yes or no, and description of product with given dose Noted on the recovery

Time arrival recovery to time leaving recovery, time notation on arrival and leaving Noted on the recovery

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)

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