Comparison of Midazolam (Versed) and Distraction on Anxiety, Emergence Delirium, Sedation/Agitation, and Vomiting in Pre-operative Patients Ages 3 to 5.
Phase: NA
Conditions: Anxiety
Sponsor: The Cleveland Clinic

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Study Protocol 
 
 
Comparison of Midazolam (Versed) and Distraction on Anxiety, Emergence Delirium, 
Sedation/Agitation, and Vomiting in Pre-operative Patients ages 3 to 5  
Principal Investigator:  
Michelle Levay, MSN, RN, CPN, Assistant Nurse Manager, 
levaym@ccf.org, ph: 216-444-9515 
Co-Investigators: 
• Megan Sumser, BSN, RN, CPN, Staff Nurse, sumserm@ccf.org, ph: 216-445-8697 
• Vatula Seward, RN, CPN, Staff Nurse, sewardv@ccf.org, ph: 216-445-8697 
• Jane Dingenary, RN, CPN, Staff Nurse, dingenj@ccf.org, ph: 216-445-8697 
• Shannon Sonnhalter, BS, CCLS, Senior Child Life Manager, sonnhas@ccf.org,                        
ph: 216-952-7420 
• Jacquelyn Mason BSN, RN, CPN, Staff Nurse, masonj2@ccf.org, ph: 216-445-8697 
• Erin Kampman RN, CPN, Staff Nurse, kampmae@ccf.org, ph: 216-445-8697 
• Marie Romanak BSN, RN, CPN, Staff Nurse, romanam@ccf.org, ph: 216-445-8697 
• Andrea Sammon MS, Child Life Specialist, sammona@ccf.org, ph: 216-445-8697 
• Dr. Alina Bodas, MD, Staff Anesthesiologist, bodasa@ccf.org, ph: 216-217-0309 
• Kristen Vargo, MSN, RN, Nurse Manager Pediatric PACU/Same Day Surgery, 
vargok3@ccf.org, ph: 216-386-9718 
 
Consultants: 
• James Bena MS, Lead Statistician, Quantitative Health Sciences benaj@ccf.org, ph: 216-
445-2336 
• Sandra Siedlecki, PhD, RN, CNS, Senior Nurse Scientist, siedles@ccf.org, ph: 216-444-
3896 
 
 
 
 
 
 
 
 

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Purpose, Specific Aims, and Research Questions 
The primary purpose of this study is to compare diversion as a non-pharmacological method of 
reducing pre-operative anxiety in children ages 3-5 years old. A secondary purpose is to compare 
the incidence of emergence delirium, sedation/agitation, and vomiting between groups who used 
diversion as opposed to midazolam (Versed) to manage preoperative anxiety. 
Specific aim 
For this study, the diversion activity will include an interactive tablet-like electronic distraction 
device (ITEDD).  The specific aim of this study is to compare the effect of the ITEDD versus 
oral midazolam (Versed) on pre-operative anxiety, post-operative emergence delirium (ED), 
sedation/agitation, and vomiting between groups of children ages 3-5. 
Research Questions 
 
1. Research Question: Is there a difference in anxiety in children aged 3-5 who received 
ITEDD vs. patients who received oral midazolam (Versed)? 
2. Research Question: Is there a difference in the incidence of emergence delirium in 
children aged 3-5 year of age who received ITEDD vs. those who received oral 
midazolam (Versed)? 
3. Research Question:  Is there a difference in sedation/agitation level pre- and post-
operatively in children aged 3-5 years who received ITEDD vs. those who received oral 
midazolam (Versed)? 
4. Research Question:  Is there a difference in the incidence of post-operative vomiting in 
children 3-5 years who received ITEDD vs. those who received oral midazolam 
(Versed)? 
 
Background/Review of Literature/Significance  
As research has shown, pre-operative anxiety in children can have a lasting impact on a child and 
the current methods of controlling pre-operative anxiety in children is limited by the side effects 
of the medications used to treat pre-operative anxiety. It is important for nurses to investigate the 
effectiveness of non-pharmacologic interventions that can help to manage pre-operative anxiety 
and yet are not associated with adverse effects. In preparation for this study the literature was 
reviewed as it related to optimizing immediate post-operative outcomes in pediatric patients ages 
3 to5 years old.  The prevalence of pre-operative anxiety is high in children and is associated 
with crying, separation anxiety, and temper tantrums in as many as 88% of children following 
surgery” (Kain et al., 1996).  Many children will develop anxiety associated with unknown 
procedures, unfamiliar surroundings, and parental separation (Kain et al., 2004). The standard 
treatment for preventing this anxiety pre-operatively is to medicate children with oral midazolam 
(Versed).  However, midazolam (Versed) is not without side effects, and is specifically linked to 
emergence delirium, sedation/agitation, and vomiting post-operatively (Taketomo, 2012).   
In the literature several studies were found that examined strategies to reduce anxiety in pediatric 
surgery patients. Kain et al. (1999) found that midazolam (Versed) was more effective than no 
pre-medication for managing anxiety in children, but side effects of midazolam (Versed) were 

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not examined. Thus the routine administration of pre-operative sedation midazolam (Versed) has 
proven to be beneficial to increase pediatric cooperation and reduce negative behavior (Kain 
1996).  However, the use of midazolam (Versed) as a pre-operative sedation can have harmful 
side-effects.  These side effects can include respiratory depression, apnea, CNS depression, 
hypotension, nausea/vomiting, emergence delirium, and paradoxical reactions including 
increased aggression and agitation (Taketomo, 2012).   
Since side effects can limit the usefulness of midazolam (Versed) for managing pre-operative 
anxiety in children, we looked in the literature for evidence of non-pharmacologic interventions.  
In a systematic review reported by Yip et al (2010) the authors found several non-pharmacologic 
interventions that were as effective as midazolam (Versed) for managing anxiety in children. 
Among those non-pharmacologic interventions that showed promise was the use of distraction 
with interactive devices.  
When examining the literature associated with the use of interactive devices for managing pre-
operative anxiety in children, only three studies were found. Lee and others (2013) in a three-
group randomized controlled trial of children ages 1 to 10 found low doses of midazolam 
(Versed) in combination with diversion using a smart phone were more effective in reducing 
anxiety than either midazolam (Versed) or diversion alone. However, the incidence of side 
effects between groups was not examined. One major limitation in this study was the wide age 
range and the relatively small sample size. Thus, it is not known if the diversion activity is as 
useful in younger children as it is in older children. Likewise, in a study reported by Patel and 
others (2006), a diversion activity using a handheld tablet-like device resulted in less anxiety 
than the midazolam (Versed) group. However, they also did not compare the incidence of 
emergence delirium, sedation/agitation, or vomiting post-operatively and their sample was too 
small to examine individual age groups. Since the mean age of their sample was >8 years, it is 
not known if this intervention would be useful for younger children.  
Finally, Seiden and others (2014) in a two-group randomized controlled trial also found that 
children who used a tablet-like diversion device had less anxiety (p <.001) compared to those 
who received oral midazolam (Versed) but only after removing those less than two years of age 
from their sample. This study also found that the diversion group had less emergence delirium 
and a shorter time to discharge as compared to the midazolam (Versed) group.  In addition, 
midazolam (Versed) and anesthesia side effects such as sedation/agitation, and vomiting were 
not compared in this study.  
While several researchers have now reported that the use of a diversion device is as effective (or  
more effective) than oral midazolam (Versed) for managing pre-operative anxiety in children, 
these studies consisted of older children and it is still not known if children 3-5 years of age 
would have the same outcomes as older children. It is also not known if a diversion activity 
compared to midazolam (Versed) will result in less sedation/agitation or less post-operative 
vomiting than is seen with midazolam (Versed). Thus the purpose of this study is to improve 
upon the previous studies to see if use of an interactive tablet-like diversion device (ITEDD) is 
useful for managing pre-operative anxiety in children 3-5 years of age; and to see if it results in 
fewer adverse effects such as emergence delirium, sedation/agitation, or vomiting. 
Variables 

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Anxiety: Every year nearly 5 million children in the United States undergo elective surgery and 
nearly 50% of them exhibit some degree of pre-operative anxiety (Kain et al 2006).  Anxiety is 
defined as a painful or apprehensive uneasiness of mind usually over an impending or anticipated 
ill (Merriam Webster Inc., 2015).  Pre-operative anxiety in children is associated with an increase 
in post-operative pain, an increase consumption of analgesics, and sleep disturbances (Kain et 
al., 2006).     
Emergence Delirium (ED) is defined as a “mental disturbance during the recovery from general 
anesthesia consisting of hallucinations, delusions, and confusion manifested by moaning, 
restlessness, involuntary physical activity, and thrashing about in bed” (Sikich et al., 2004).  
While children are experiencing ED they are at risk for harming themselves and their caregivers. 
The incidence of ED in pediatric patients is estimated at anywhere from 18 to 80% (Sikich et al., 
2004).  Furthermore, children having ENT procedures ages 2- to 5 years old are at an even 
higher risk. One of the side effects of midazolam (Versed) is paradoxical reaction with 
“behavioral changes and agitation” (Seiden et al., 2014).  Paradoxical reaction occurs in 2% of 
cases (Taketomo, 2012).   
Sedation/Agitation:   Pediatric patients that exhibit signs and symptoms of anxiety are routinely 
given oral midazolam (Versed) preoperatively (Lee et al., 2013). However, midazolam (Versed) 
is not without side effects and these include excessive sedation, depressed respiratory status, 
altered mental status, paradoxical reactions, and possible anaphylaxis (Taketomo, 2012).   
Vomiting: Post-operative vomiting is a common side effect of sedation medication and 
anesthesia.  Administration of midazolam (Versed) is a contributing factor to increased incidence 
of vomiting (Taketomo, 2012).  Nearly all patients receiving general anesthesia are given anti-
emetics in an attempt to avoid the unpleasant side effect. However, they are only partially 
effective and have their own side-effects.  Ondansetron is a commonly prescribed anti-emetic 
after surgery and the side effects of this drug include tachycardia, lightheadedness, rash, 
hypokalemia, constipation, transient elevations in liver enzymes, weakness, blurred vision, 
bronchospasm, and hypersensitivity reactions (Taketomo, 2012).   
Theory 
According to Erik Erickson, children ages 3 to5 years old (early childhood), are within the 
psychosocial stage of initiative versus guilt (Santrock, 2003).  Within this framework, children 
take initiative within the world around them creating a sense of accomplishment and mastery. 
Children in this stage of development benefit from asserting control, by exploring the world 
around them, and by accomplishing tasks on their own.  We propose that children having the 
autonomy to choose games on the ITEDD will experience either the same or decreased anxiety 
and less emergence delirium, sedation/agitation, and vomiting, when compared to children who 
are medicated with midazolam (Versed).     
Methodology 
Design 
A 2-group randomized control trial will be used to answer the research questions.  
 
 

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Recruitment Procedure 
A representative from the research team will contact the family after the preoperative office visit 
to review inclusion/exclusion criteria and determine eligibility for study.  If the patient is 
determined to be a candidate for the study, the researcher will explain the study to the parents. 
Written informed consent from the parent and assent from the minor child will be obtained prior 
to surgery. 
Sampling and Group Assignment 
Stratified random assignment will be used to maximize the likelihood that the groups will be 
similar at baseline and will not differ on two important variables (age and interaction with Child 
Life Services). Since it is anticipated that a 3- and 5-year-old may respond differently to the 
interventions it is important that the groups have a similar number of children of each age to 
prevent our findings from being affected by any one age. This will be controlled both statistically 
and by design using stratified random assignment.  Interaction with a Child Life Specialist will 
vary. Child Life Specialists (CLS) are trained to help children and their families cope with 
surgery, illness, and hospitalizations.  The CLS will assess the need for child life services using 
communication with nursing staff, observations of patient/family, child and family relationships, 
chart reviews and availability (this is a usual and customary care procedure). The CLS will 
evaluate and prioritize which patients in the area will receive child life service interaction that 
day. Thus, not all patients in our study will receive this interaction. Since not all children in our 
study will receive child life services and it is suspected that differences in outcomes may be 
related to this interaction, we will control for this variation both statistically and by design. Thus, 
group assignment will be stratified to control for age and child life services interaction. 
Stratified Random Assignment Procedure  
On the day of surgery, the investigator will choose one of two envelopes based on child life 
services:  one envelope states “will receive child life services” or “will not receive child life 
services.” Inside the chosen envelope will be the three additional envelopes indicating the age of 
the patient. The investigator will select the envelope with the appropriate age. This envelope will 
be presented to the patient’s parent who will then blindly select the card from the last envelope 
indicating either Group A or Group B (see Figure 1).   
  

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Figure 1 
 
Two variations based on Child Life Services: 
1. Patient enrolled in study will receive Child Life services. 
2. Patient enrolled in study will not receive Child Life services 
 
 
 
 
 
 
 
Patient Enrolled in 
the Study
Recieve Child Life 
Services
3 Years Old
Group A
Group B
4 Years Old
Group A
Group B
5 Years Old
Group A
Group B
Does Not Recieve 
Child Life Services 
3 Years Old
Group A
Group B
4 Years Old
Group A
Group B
5 Years Old
Group A
Group B

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Sample and sample size 
The study group will consist of 130 pre-school aged children 3-5 years who will be undergoing 
elective ENT, Ophthalmology, Urological, General Surgery, Neurology, and Plastic Surgery 
including tonsillectomy, adenoidectomy, T&A, placement or removal of ear tubes (unilateral and 
bilateral), strabismus, nasal lacrimal duct probing, inguinal hernia repair, hydrocele, orchiopexy, 
circumcision, meatotomy, chordee repair, umbilical hernia repair, nevus removal, removal of 
benign mass, Botox injections, lesion/cyst removal, soft tissue biopsy, excision finger 
syndactyly, and otoplasty under general anesthesia.  Sample size was determined assuming a 2-
point difference, an alpha of .05, a power of .80, and a moderate effect size. It was estimated that 
this study would require a sample of 65 patients per group (James Bena MS, biostatistician). 
Inclusion criteria 
Children selected for the study will be classified as ASA Class I and II. This is the American 
Society of Anesthesiologist’s grading system used to assess the degree of a patient’s "sickness" 
or "physical state" prior to selecting the anesthetic or prior to performing surgery.  
Included will be patients meeting Class I criteria. These include those who normal healthy 
patients with no organic, physiologic, or psychiatric disturbances.  
Also included will be patients meeting ASA Class II criteria are those who have only mild 
systemic disease no functional limitation, well-controlled disease of one body system, diabetes 
without systemic effects, or mild obesity.  
The patients selected for this study will be those who meet the ASA Class I and II criteria and 
are scheduled for elective surgeries including tonsillectomy, adenoidectomy, combination tonsil 
and adenoidectomy (T&A), placement or removal of ear tubes, strabismus, nasal lacrimal duct 
probing, inguinal hernia repair, hydrocele, orchiopexy, circumcision, meatotomy, chordee repair, 
umbilical hernia repair, nevus removal, removal of benign mass, Botox injections, lesion/cyst 
removal, soft tissue biopsy, excision finger syndactyly, and otoplasty under general anesthetic, 
with mask induction of anesthesia.  
Exclusion criteria 
Children younger than 3 or older than 6, or children having any procedure other than 
tonsillectomy, adenoidectomy, T&A, placement or removal of ear tubes, strabismus, nasal 
lacrimal duct probing, inguinal hernia repair, hydrocele, orchiopexy, circumcision, meatotomy, 
chordee repair, umbilical hernia repair, nevus removal, removal of benign mass, Botox 
injections, lesion/cyst removal, soft tissue biopsy, excision finger syndactyly, and otoplasty will 
be excluded from this study.   
Likewise, children who do not meet the criteria for ASA Class I or II will be excluded from this 
study.  
Children will be excluded if Anesthesia determines that it would be in the best interest of the 
patient to be pre-medicated with midazolam (Versed) prior to surgery.  
Also excluded will be children with cognitive and/or developmental delays, children going 
directly to the ICU from the operating room and children with an allergy to midazolam.  

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Procedures 
Control group: Once written informed consent has been obtained from the parent, the parent 
will be asked to select an envelope from the package of envelopes for that child’s strata (age and 
Child life interaction). The researcher will open the envelope in front of the parent and explain 
the group assignment to both the child and the parent: “Your child has been assigned to the 
control group.  Children in this group receive the usual and customary pre-operative care which 
consists of premedication for anxiety. As part of the study the child will be assessed for anxiety 
and sedation/agitation pre-operatively.  Post-operatively we will assess emergence delirium, 
sedation/agitation, and vomiting.”  
Experimental group: Once written informed consent has been obtained from the parent, the 
parent will be asked to select an envelope from the package of envelopes for that child’s strata 
(age and Child Life interaction). The researcher will open the envelope in front of the parent and 
explain the group assignment to both the child and the parent: “Your child has been assigned to 
the distraction group. Children in this group will receive usual and customary preoperative care 
but will be asked to play with an ITEDD pre-operatively. Your child will be assessed for anxiety 
and sedation/agitation preoperatively.  Post-operatively we will assess emergence delirium, 
sedation/agitation, and vomiting.”   
Children in the experimental group that are not interested in playing with the interactive tablet-
like distraction device will be removed from the study.  Children will then receive the usual and 
customary pre-operative care which consists of premedication (midazolam/Versed) for anxiety. 
Routine standard of care: 
Patients will check in at P20 Surgical registration desk and then be assigned a pre-operative 
room in M20.  Nursing staff will complete assessment questions in EPIC and orient patients and 
families to the pre-operative environment.  
Control Group (Group A): 
Patients in the control group will receive routine standard of care during the study.  Study 
participants assigned to control group will receive the usual oral midazolam per Anesthesia.  
Patients will remain in M20 for 15 to 20 minutes to allow for the onset of action of midazolam 
(Versed) and will then be escorted to the operating room with parental accompaniment. 
Experimental Group (Group B): 
Patients in the experimental group (group B) will receive routine standard of care during the 
study.  Study participants in group B will be given an ITEDD and will choose developmentally 
appropriate games (see appendices) and activities on the ITEDD. Patients will then be escorted 
to the operating room while continuing to use the ITEDD with parental accompaniment.     
The child will be allowed to independently choose which games he or she would like to play and 
will have the ability to change to another game at any point.  This will allow the child to exert 
control over real world scenarios (such as playing hair salon) and play games that include tasks 
that they can successfully master on their own (such as puzzles and letter recognition).  The child 
will have unlimited play prior to going to the Operating Room (OR) as well as during induction 
in the OR.  

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The following games were chosen to be downloaded on the ITEDD using knowledge of 
developmental milestones for children from ages 3-5 years as well as games that would 
challenge the skills of the child to maintain distraction.  Child Life Services served as a 
consultant on game and activity selections appropriate to this age group. 
 
Game 
Recommended Age Ranges 
Description 
Elmo Loves ABCs 
3-6 years 
Letter recognition & tracing along with videos 
& songs 
Dora’s ABCs Vol1: Letters 
and Sounds 
3-6 years 
Learning letter sounds and practicing tracing 
upper & lowercase letters 
Preschool Monkey Lunchbox 
3-6 years 
Randomized activities such as matching, letter 
recognition, differences, counting, & puzzles  
Art of Glow 
3-6 years 
3-4 years with assistance  
Drawing with various shapes   
Cut the Rope HD 
5-6 years 
5 years with assistance 
Using a finger to cut the rope to drop a piece of 
candy into a monster’s mouth using physics  
Where’s My Water? 
4-6 years 
4-5 years with assistance  
Clearing obstacles out of the way to create a 
path to get water to the shower for an alligator  
Cake Doodle 
3-6 years 
3 years with assistance  
Choosing and mixing ingredients in order to 
bake a cake & then decorate the cake   
Toca Hair Salon  
3-6 years 
Wash, cut, and style hair on various characters  
Toonia Colorbook 
3-6 years 
Variety of coloring pages  
Shiny Party 
3-5 years  
Interactive story as well as a game mode with 
shape recognition, matching, & puzzles  
Sonic Dash 
5-6 years 
5 years with assistance 
Hedgehog endlessly running to collect rings 
and dodge obstacles  
Lego Juniors Create and 
Cruise 
3-6 years 
3 years with assistance  
Drive or fly a vehicle that you build from Legos 
Match Blitz 
4-6 years  
A multiplayer matching game when the first 
person to 10 matches wins 
Disney Junior Appisodes—
Mickey Mouse Road Rally 
3-6 years 
Interactive Mickey Mouse episode  
You Tube Kids 
4-6 years 
4-5 years with assistance  
A portal to search, listen to, & watch TV shows, 
music, and educational videos geared toward 
children  
Setting 
The study will take place on the M20 nursing unit and pediatric operating rooms. 

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Data Collection 
Basic demographic information will be collected at the time of random assignment and will 
include age, race, gender, and scheduled procedure. No Protected Health Information (PHI) is 
needed for this study. All findings will be reported in the aggregate and every effort will be made 
to ensure privacy and confidentiality of all patient data.  Subjects will only be identified by a 
study number and all data will be kept secured in a locked file in a locked office accessible only 
to the study staff. 
Outcome Measures 
Outcomes to be measured include:  
1. Pre-induction anxiety as measured by the m-YPAS scale (see appendix 1) after 
having received either pre-operative: 
a. Medication with PO midazolam and parental presence during induction. 
b. ITEDD and parental presence during induction. 
2. Sedation/Agitation score via the RASS (see appendix 2). 
3. Incidence of post-operative emergence delirium (ED) as measured by the PAED 
scale.  
4. Incidence of post-operative vomiting.  If POV occurred was pharmacological 
intervention required. 
 
 
Induction OR 
Admit to PACU 
Wake-up from 
anesthesia 
Anxiety 
m-YPAS 
 
 
Emergence Delirium 
 
 
PAED 
Sedation/Agitation 
RASS 
RASS 
 
Vomiting 
 
POV 
POV 
 
Instruments/Tools/Measurement Methods: 
Anxiety will be assessed using modified Yale Preoperative Anxiety Scale (m-YPAS) to measure 
anxiety in children during induction of anesthesia. The m-YPAS has been found to be a useful 
and valid tool for measuring anxiety in pediatric patients ages 2-6 (Kain et al. 1997). The m-
YPAS has 22 numerically weighted items separated into five categories, scores range from 22 
(no anxiety) to 100 (high level of anxiety).  
Sedation/agitation will be assessed using the Richmond Agitation Sedation Score (RASS).  This 
tool will be administered in pre-operative holding area, at induction, and on admission to the 
PACU postoperatively.  The RASS is a 10-item tool completed by the nurse and based on 
nursing observations of behavior. Scores on the RASS can range from -5 (unarousable) to +4 
(highly agitated and combative).  The RASS tool has demonstrated excellent validity, reliability 
and is used at the Cleveland Clinic to evaluate patients in the recovery room (Ely et al., 2003).   
The Pediatric Anesthesia Emergence Delirium Scale (PAED) will be used to assess patients for 
presence of emergence delirium in the PACU. The PAED is an observational tool used by the 
nurse/evaluator. Previous studies suggest this is a valid measure of ED in pediatric patients 

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(Sikich et al., 2004). The PAED tool contains 5 items on the patients’ behavior.  The first 3 
questions are reverse scored (4 = not at all; 3=just a little; 2=quite a bit; and 1=very much) and 
the last 2 questions are scored as follows (0=not at all; 1=just a little; 2=quite a bit; 3=very much; 
and 4=extremely).  Scores on the PAED scale can range from 0 to 20.  The authors of the PAED 
scale reported scores of >10 correspond to a “sensitivity of 0.64 and a 1-specificity of 0.14”.  
Inter-observer reliability of the PAED was noted at 0.84 and deemed an acceptable instrument of 
emergence delirium (Sikich et al., 2004). Bajwa (2010) reported sensitivity of 100% and 
specificity of 94.5% for a score of >12 for the PAED when used by an experienced observer; 
thus, for purposes of this study scores >12 will be considered evidence of ED. 
Vomiting will be assessed as a positive occurrence when child is actively vomiting and will be 
recorded on the data collection instrument as present or absent during the PACU stay. 
The investigators will be responsible for monitoring data collection and storing data collection 
forms in a locked cabinet in the PIs locked office.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 1 
The m-YPAS 
Activity 
1. 
Looking around, curious, playing with toys, reading (or other age appropriate 
behavior); moves around holding area/treatment room to get toys or to go to parent; may 
move toward operating room 
2. 
Not exploring or playing; may look down, fidget with hands, or suck thumb 
(blanket); may sit close to parent while waiting or play has a definite manic quality. 
3. 
Moving from toy to parent in unfocused manner; non-activity-derived movements; 
frenetic/frenzied movement or play; squirming, moving on table; may push mask away or 
cling to parent. 
4. 
Actively trying to get away, pushes with feet and arms, may move whole body; in 
waiting room, running around unfocused, not looking at toys, will not separate from parent, 
desperate clinging. 
Vocalizations 
1. 
Reading (non-vocalizing appropriate to activity), asking questions, making 
comments, babbling, laughing, readily answers questions but may be generally quiet; child too 
young to talk in social situations or too engrossed in play to respond 
2. 
Responding to adults but whispers, “baby talk,” only head nodding 
3. 
Quiet, no sounds or responses to adults 
4. 
Whimpering, moaning, groaning, silently crying 
5. 
Crying or may be screaming “no” 
6. 
Crying, screaming loudly, sustained (audible through mask) 
Emotional Expressivity 
1. 
Manifestly happy, smiling, or concentrating on play 
2. 
Neutral, no visible expression on face 
3. 
Worried (sad) to frightened, sad, worried, or tearful eyes 
4. 
Distressed, crying, extreme upset, may have wide eyes 
State of Apparent 
Arousal 
1. 
Alert, looks around occasionally, notices or watches what anesthesiologist does 
(could be relaxed) 
2. 
Withdrawn, sitting still and quiet, may be sucking thumb or have face turned into 
adult. 
3. 
Vigilant, looking quickly all around, may startle to sounds, eyes wide, body tense 
4. 
Panicked whimpering may be crying or pushing others away, turns away. 
Use of Parents 
1. 
Busy playing, sitting idle, or engaged in age appropriate behavior and doesn’t need 
parent; may interact with parent if parent initiates the interaction. 
2. 
Reaches out to parent (approaches parent and speaks to otherwise silent patient), 
seeks and accepts comfort, may lean against parent 
3. 
Looks to parent quietly, apparently watches actions, doesn’t seek contact or 
comfort, accepts it if offered or clings to parent 
4. 
Keeps parent at distance or may actively withdraw from parent, may push parent 
away or desperately clinging to parent and not let parent go 

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Appendix 2 
The Pediatric Anesthesia Emergence Delirium Scale 
The child makes eye contact with the 
caregiver. 
4     Not at all 
3     Just a little 
2     Quite a bit 
1     Very Much 
0     Extremely 
The child’s actions are purposeful. 
4     Not at all 
3     Just a little 
2     Quite a bit 
1     Very Much 
0     Extremely 
The child is aware of his/her surroundings. 
4     Not at all 
3     Just a little 
2     Quite a bit 
1     Very Much 
0     Extremely 
The child is restless 
0     Not at all 
1     Just a little 
2     Quite a bit 
3     Very much 
4     Extremely 
The child is inconsolable. 
0     Not at all 
1     Just a little 
2     Quite a bit 
3     Very much 
4     Extremely 
 
 
 
 
 
 
 
 
 
 

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Appendix 3 
Richmond Agitation Sedation Scale (RASS) * 
 
Score Term Description 
+4  Combative Overtly combative, violent, immediate danger to staff 
+3  Very agitated Pulls or removes tube(s) or catheter(s); aggressive 
+2  Agitated Frequent non-purposeful movement, fights ventilator 
+1  Restless Anxious but movements not aggressive vigorous 
0    Alert and calm 
-1   Drowsy Not fully alert, but has sustained awakening (eye-opening/eye contact) to voice (>10     
seconds) 
-2  Light sedation Briefly awakens with eye contact to voice (<10 seconds) 
-3  Moderate sedation Movement or eye opening to voice (but no eye contact) 
-4  Deep sedation No response to voice, but movement or eye opening to physical stimulation 
-5  Unarousable No response to voice or physical stimulation 
 
Procedure for RASS Assessment 
1. Observe patient 
a. Patient is alert, restless, or agitated. (score 0 to +4) 
2. If not alert, state patient’s name and say to open eyes and look at speaker. 
b. Patient awakens with sustained eye opening and eye contact. (score –1) 
c. Patient awakens with eye opening and eye contact, but not sustained. (score –2) 
d. Patient has any movement in response to voice but no eye contact. (score –3) 
3. When no response to verbal stimulation, physically stimulate patient by shaking shoulder 
and/or rubbing sternum. 
e. Patient has any movement to physical stimulation. (score –4) 
f. Patient has no response to any stimulation. (score –5)