Comparison of Outcomes During MRI Sedation With Midazolam-dexmedetomidine Versus Ketamine-dexmedetomidine
Phase: NA
Conditions: Sedation
Sponsor: University of Louisville

 
 
 
 
 
 
COMPARISON OF OUTCOMES DURING MRI SEDATION WITH MIDAZOLAM-
DEXMEDETOMIDINE VERSUS KETAMINE-DEXMEDETOMIDINE 
Version 2.0 
April 2, 2014 
 
 
PRINCIPAL INVESTIGATOR:  
John W. Berkenbosch, MD 
CO- INVESTIGATOR: 
 
 
Janice E Sullivan, MD 
 
 
John W Berkenbosch, MD 
University of Louisville 
Department of Pediatrics 
Division of Pediatric Critical Care 
571 S Floyd, Ste 332 
Louisville, KY 40202 
502-852-3720 
John.berkenbosch@louisville.edu 
 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
2 
 
Table of Contents: 
Background  
 
 
 
 
 
 
 
3 
Study Purpose 
 
 
 
 
 
 
 
5 
Rationale 
 
 
 
 
 
 
 
 
5 
Hypothesis and Research Aims 
 
 
 
 
 
5 
Outcomes 
 
 
 
 
 
 
 
 
6 
Study Design  
 
 
 
 
 
 
 
7 
Inclusion Criteria 
 
 
 
 
 
 
 
9 
Exclusion Criteria 
 
 
 
 
 
 
 
9 
Procedures  
 
 
 
 
 
 
 
9 
Risks  
 
 
 
 
 
 
 
 
13 
Statistical Analysis  
 
 
 
 
 
 
15 
References 
 
 
 
 
 
 
 
 
16 
Study Event Table  
 
 
 
 
 
 
20 
Case Report Form  
 
 
 
 
 
 
21 
 
 
 
 
 
 
 
 
 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
3 
 
Background 
Non-invasive radiologic studies such as MRI play an increasingly important role in the 
evaluation of pediatric patients with both acute and chronic disease.  Due to their 
developmental capacities, procedure-related anxiety, and the need for a near 
motionless state during these studies, children often require moderate to deep sedation 
for the completion of these procedures.   
Historically, many different sedative regimens have been used to sedate children for 
these studies.  These regimens have included chloral hydrate (1, 2), sodium 
pentobarbital (3-5), and propofol (5-7).  While each of these agents has been reported 
to be successful, they also have potential disadvantages.  Chloral hydrate has a highly 
variable onset and dissipation of action (2), has been associated with a higher sedation 
failure rate in older children and those with various neuro-behavioral diagnoses (8) and 
is no longer available in the United States.  Pentobarbital use has been associated with 
a risk of respiratory depression and significant recovery related agitation (2, 9).  While 
propofol has become one of the most popular agents for pediatric sedation, it also can 
cause significant respiratory depression and/or hypotension (10, 11).   
Dexmedetomidine is an 2-adrenoreceptor agonist with both sedative and analgesic 
properties.  It has been used to effectively provide pediatric procedural sedation for 
radiology procedures and has become an increasingly popular choice for non-invasive 
procedural sedation in recent years (12-14).  Compared to other agents, the main 
appeals of dexmedetomidine include limited respiratory suppression, a simulation of 
more natural sleep, minimal effects on the EEG, and limited adverse behavioral 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
4 
 
reactions, both during the induction and recovery phases.  The most significant 
reported adverse effects with dexmedetomidine sedation have included hypotension 
and bradycardia (15, 16). While rarely requiring intervention, these effects may be 
managed by decreasing the infusion rate, fluid administration, or use of an 
anticholinergic such as glycopyrollate although profound hypertension has been 
reported with this intervention (17).  
In response to the hypotension-inducing effects of several sedatives commonly used, 
practitioners have co-administered hypotension-sparing agents to ameliorate this effect.  
The primary agent used for this purpose is ketamine, a sympathomimetic agent which 
tends to cause hypertension, tachycardia, and, to a lesser degree, respiratory 
stimulation.  While the addition of ketamine to propofol appears to have inconsistent 
effects on propofol-induced respiratory depression, the combination has been reported 
to result in improved hemodynamic preservation (18-20).  However, because propofol is 
a very short-acting agent, the use of this combination may still be associated with the 
development of emergence reactions not uncommonly seen with ketamine.   
More recently, interest has also increased in using ketamine as a co-sedative with 
dexmedetomidine in an effort to blunt the hemodynamic effects seen with 
dexmedetomidine alone or when combined with a benzodiazepine such as midazolam. 
Additionally, as dexmedetomidine has a longer duration of action compared to 
ketamine, emergence reactions could potentially be less problematic than during 
ketamine sedation alone or during propofol-ketamine sedation.  Unfortunately, few data 
have actually described the results of this combination in pediatric sedation to date. 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
5 
 
During cardiac catheterization, different dosing combinations of ketamine-
dexmedetomidine were associated with good analgesia for catheter insertion and 
minimal adverse cardiovascular or respiratory adverse effects (21, 22). Similarly, when 
used for burn dressing changes, ketamine-dexmedetomidine provided equivalent 
analgesia and cardiovascular stability with improved respiratory preservation compared 
to ketamine-propofol (23).  However, in these settings, ketamine was added to 
dexmedetomidine or propofol primarily for its potent analgesic effects.  No data to date 
have compared ketamine-dexmedetomidine to dexmedetomidine alone or 
dexmedetomidine-midazolam sedation for non-invasive or non-painful procedures. 
For the past 6-7 years, dexmedetomidine (with or without midazolam) has been the 
sedative regimen of choice for MRI sedation for our Critical Care-based sedation service 
(UCSS).  In the last 2-3 years, we have also been incorporating ketamine into this 
regimen.  It has been the impression of providers using this combination that with 
ketamine-dexmedetomidine, patients fall asleep more quickly, have less hypotension, 
and do not have emergence reactions when they wake up. The current study proposes 
to more rigorously evaluate these questions. 
 
 
 
 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
6 
 
Study Purpose 
The purpose of this prospective, double-blind, randomized trial is to compare the impact 
of midazolam or ketamine coadministration on various sedation-related outcomes 
during dexmedetomidine sedation for MRI studies. 
 
Rationale 
While this combination is being used more and more frequently by sedation 
practitioners, based on a presumption that the 2 together augment sedation efficiency 
and decrease sedation-related adverse events, the data supporting these assumptions 
remains lacking. The current study would specifically address these important 
questions. 
 
Hypotheses and Research Aims: 
1) We hypothesize that the coadministration of ketamine with dexmedetomidine 
for MRI sedation will result in improved sedation efficiency (decreased 
induction time), improved preservation of cardiovascular stability, and not 
increase sedation-related adverse recovery events when compared to 
sedation with midazolam-dexmedetomidine. 
The primary questions/outcomes of interest are: 
1) 
Does ketamine coadministration, compared to midazolam 
coadministration, decrease or blunt the development of bradycardia 
and/or hypotension during dexmedetomidine sedation? 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
7 
 
2) 
Does ketamine coadministration, compared to midazolam 
coadministration, improve the efficiency of sedation (decreased 
induction time, shorter recovery time) during dexmedetomidine 
sedation? 
3) 
Does ketamine coadministration, compared to midazolam 
coadministration, increase the incidence of adverse recovery-related 
behaviors during dexmedetomidine sedation? 
 
Outcomes 
1) The primary outcome of interest will be to assess the impact of ketamine vs 
midazolam administration on cardiovascular changes during dexmedetomidine 
sedation 
2) Our secondary outcomes will be to: 
a. Compare induction and recovery times between patients sedated with 
ketamine-dexmedetomidine vs midazolam-dexmedetomidine as a measure 
of sedation efficiency. 
b. Evaluate the incidence of adverse recovery-related behaviors between the 
2 study groups, including overt emergence reactions. 
 
Study Design 
The will be a randomized, double-blind, prospective study.   All patients referred to 
UCSS for brain MRI and for whom dexmedetomidine would otherwise be the sedation 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
8 
 
regimen of choice will be eligible for enrollment.  We propose to limit the study to 
patients undergoing only brain MRI as these studies are of a predictable length (25-30 
minutes); therefore the sedation regimen can be more easily standardized.  Parents of 
eligible patients would be approached prior to or during the pre-sedation assessment 
and told about the study and, if they agree to enroll, informed consent would be 
obtained.  Assent will be obtained from children 7 years of age and greater, if they are 
otherwise developmentally capable of giving assent. The goal is to enroll 50 subjects 
(25 per treatment group) which would be sufficient to detect a 25% or greater 
difference in the mean maximal heart rate or blood pressure decrease from baseline 
between the 2 groups. 
Following consent, subjects would be randomized to be sedated with either midazolam-
dexmedetomidine or ketamine-dexmedetomidine and, upon achieving an appropriate 
depth of sedation, undergo their MRI.  Monitoring during the MRI and subsequent 
recovery would occur in compliance with the current Norton Children’s Hospital 
Sedation policy. Recovery-related behavior would be assessed using the Pediatric 
Anesthesia Emergence Delirium Scale (PAED, ref 24). This scale is described in Table 1. 
Table 1: Pediatric Anesthesia Delirium Scale: 
Item 
Description 
Not at all 
Just a 
little 
Quite a 
bit 
Very 
much 
Extremely 
1 
Child makes eye contact with caregiver 
4 
3 
2 
1 
0 
2 
Child’s actions are purposeful 
4 
3 
2 
1 
0 
3 
Child is aware of his/her surroundings 
4 
3 
2 
1 
0 
4 
Child is restless 
0 
1 
2 
3 
4 
5 
Child is inconsolable 
0 
1 
2 
3 
4 
** a sum score of 12 or greater is indicative of emergence delirium 
 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
9 
 
Inclusion Criteria 
1) Inpatient at Norton Children’s Hospital. 
2) Order placed by treating team for MRI of the brain with sedation. 
3) Age less than or equal to 18 years. 
4) Plan to sedate with dexmedetomidine, regardless of study participation. 
Exclusion Criteria 
1) Previous adverse reaction to dexmedetomidine or clonidine 
2) Current use of clonidine as a routine medication 
3) Concurrent use of a heart-rate decreasing medication (digoxin, propranolol) 
4) Contraindication to ketamine use 
a. Intracranial hypertension or traumatic brain injury 
b. Intraocular hypertension of eye trauma 
c. Pulmonary hypertension requiring medical management 
5) Planned additional procedure during the sedation encounter (non-brain MRI, 
lumbar puncture, EEG etc) 
Procedures 
Study enrollment will last for 24 hours following completion of the MRI. During the 
study, the following procedures will take place: 
1) Collection of demographic information: The study team will collect data regarding 
subject age, weight, BMI, gender, primary diagnosis and reason for MRI, 
comorbidities, and concomitant medications. 
2) Following informed consent, subjects will be randomized to either midazolam-
dexmedetomidine or ketamine-dexmedetomidine. Randomization will be done by 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
10 
 
NCH pharmacy staff using a computer-based program.  A log of which group (A 
or B) each study drug is assigned  and which group each subject is randomized 
to will be maintained by pharmacy staff and will not be viewed by either study 
staff or sedation providers until completion of the study.  As both midazolam and 
ketamine look similar to each other when drawn up in a syringe, it should be 
impossible for sedation providers to visibly distinguish between them. 
Additionally, the standard concentrations of each drug differ in the same 
proportion as their standard dosing (midazolam concentration = 1 mg/ml and 
dose = 0.1 mg/ml vs ketamine concentration = 10 mg/ml and dose = 1 mg/ml).  
Therefore, the volume of study drug administered to each subject will be identical 
(0.1 ml/kg to a maximum of 4 ml) without a need for dilution of the stock 
formulation. All of these factors (pharmacy maintenance of randomization 
assignment, similarity of drug appearance, and similarity between study drugs of 
volume to be administered) should ensure that study personnel, sedation 
providers, and subjects will remain blinded to which study drug they receive.  In 
the event of a severe adverse reaction, it will be permissible for sedation 
personnel to contact pharmacy to break code for a given subject if necessary. 
However, because care for these reactions is always symptomatic support, it is 
difficult to perceive of a situation for which breaking the randomization code 
would be required to appropriately provide treatment. 
3) Following randomization, pharmacy staff will prepare the study drug doses; either 
midazolam (0.1 mg/kg, maximum dose 4 mg) or ketamine (1 mg/kg, maximum 
dose 40 mg) to be administered.  Doses of study drug will be labelled with the 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
11 
 
subjects name and group assignment (A or B), which will then be obtained by 
sedation providers prior to initiation of sedation. 
4) Sedation induction. Per UCSS standard practice, sedation induction will occur by 
administration of study drug first, followed by dexmedetomidine 2 mcg/kg.  The 
induction bolus will be administered over a 5 minute period to avoid development 
of significant hypertension and/or sinus pause which have been reported with 
rapid bolus administration (25). If sedation is inadequate to start the MRI after 
initial induction doses of study drug and dexmedetomidine, additional 0.5 mcg/kg 
doses of dexmedetomidine may be administered every 5 minutes until adequate 
sedation is achieved.  If adequate sedation is not achieved following either 4 
mcg/kg of dexmedetomidine or if clinically significant cardiorespiratory adverse 
effects develop, the encounter will be considered a sedation failure per our 
routine practice and the procedure will either be aborted or performed using 
alternative sedation as deemed appropriate by UCSS providers. 
5) MRI examination: Upon induction of adequate sedation, the subject will be 
transported to the MRI suite where the scan will occur.  Monitoring during the 
scan will be in accordance with the American Academy of Pediatrics and 
American Society of Anesthesiology sedation standards and Norton Children’s 
Hospital policy for monitoring of patients undergoing procedural sedation.  This 
will include, at minimum, continuous monitoring of heart rate (HR), respiratory 
rate (RR), oxygen saturation (SpO2) and end-tidal CO2 (ET-CO2) monitoring and 
intermittent non-invasive blood pressure (BP) measurement.   Vital signs will be 
recorded at least every 5 minutes during induction and MRI scan and at least 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
12 
 
every 15 minutes during the recovery phase.  Similarly, standard pain and 
sedation depth assessments will be performed and recorded every 5-15 minutes.  
6) Recovery: Upon completion of the MRI scan, subjects will be transported to the 
Norton Children’s Hospital sedation unit which is adjacent to the MRI scanner for 
recovery.  Vital signs and pain/sedation assessments will be performed during 
recovery as listed above.  To assess for adverse recovery-related behaviors, the 
PAED will be administered and recorded every 15 minutes during recovery by 
study personnel.  Per Norton Children’s Hospital policy, recovery will be 
considered complete once subjects have achieved an Aldrete score of 8 or 
greater on 2 consecutive assessments, at which time they will be transported 
back to their room. 
7) Follow-up: A follow up visit to ask the parents ± the subject about any problems 
or unpleasant experiences during the sedation encounter.  Specific questions of 
interest will include: 
a. Prolonged sedative effects (sleepiness/grogginess lasting more than 120 
minutes from the last dose of sedation administration) 
b. Observed (parent(s)) or recalled (subject) unpleasant visual or auditory 
experiences or hallucinations during the recovery phase. 
c. Persistent nausea/vomiting or inability to tolerate oral/enteral intake (if no 
other clinical contraindication to oral/enteral intake existed prior to study 
enrollment) 
d. Medical record will be reviewed for any signs of adverse events post-
sedation. 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
13 
 
 
Risks 
The risks of undergoing procedural sedation in general have been well defined.  These 
risks are outlined in Table 2 and are similar to those described with use of midazolam 
as well: 
Table 2: General risks of procedural sedation 
Common (>10%) 
Uncommon (1-10%) 
Rare (<1%)  
Very rare (<0.1%) but 
clinically important 
Dizziness during 
recovery 
 
 
*Minor blood pressure 
decrease 
*Minor/transient 
decrease in oxygen 
levels 
*Minor decrease in HR 
Oversedation 
Increased 
salivation/secretions 
Agitation during 
recovery 
Burning at IV site with 
sedative administration 
Nausea/vomiting 
Hallucinations 
Apnea (pause in 
respiration) 
Minor airway obstruction 
(resolves with minor 
repositioning) 
Prolonged sedation 
(>120 minutes ) 
Ineffective sedation 
(unable to complete 
procedure) 
 
Cardiac Arrest (0.003%) 
Gastric content 
aspiration (0.003) 
Seizure (0.04%) 
Laryngospasm (closure 
of the vocal cords 
obstructing breathing) 
(0.04%) 
Serious allergic reaction 
(rash/hives) (0.05%) 
Anaphylaxis (0.005%) 
* Minor is defined as a change in parameter not requiring intervention 
More specific risks associated with the use of either dexmedetomidine or ketamine are 
outlined in Tables 3 and 4:  
 
Table 3: Risks associated with ketamine use 
Common (>10%) 
Uncommon (1-10%) 
Rare (<1%)  
Very rare (<0.1%) but 
clinically important 
Dizziness during 
recovery 
Double vision during 
*Minor blood pressure 
decrease 
Agitation during 
Hallucinations 
Minor airway obstruction 
(resolves with minor 
Cardiac Arrest  
Gastric content 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
14 
 
recovery 
Elevated heart rate 
(transient) 
Elevated blood pressure 
(transient) 
Increased 
salivation/secretions 
 
recovery 
Nausea/vomiting 
Burning at IV site with 
sedative administration 
Muscle jerking (not 
seizure) 
repositioning) 
Prolonged sedation 
(>120 minutes ) 
 
 
aspiration  
Seizure  
Laryngospasm (closure 
of the vocal cords 
obstructing breathing)  
Serious allergic reaction 
(rash/hives)  
Apnea (pause in 
respiration) 
* Minor is defined as a change in parameter not requiring intervention 
 
 
Table 4: Risks associated with dexmedetomidine use: 
Common (>10%) 
Uncommon (1-10%) 
Rare (<1%)  
Very rare (<0.1%) but 
clinically important 
*Minor blood pressure 
decrease 
*Minor heart rate 
decrease 
 
 
Blood pressure decrease 
possibly requiring 
intervention 
Heart rate decrease 
possibly requiring 
intervention 
Nausea/vomiting 
Hallucinations 
Apnea (pause in 
respiration) 
Minor airway obstruction 
(resolves with minor 
repositioning) 
Prolonged sedation 
(>120 minutes ) 
Ineffective sedation 
(unable to complete 
procedure) 
Cardiac Arrest  
Gastric content 
aspiration 
Seizure (0.04%) 
Laryngospasm (closure 
of the vocal cords 
obstructing breathing 
Serious allergic reaction 
(rash/hives)  
Anaphylaxis  
* Minor is defined as a change in parameter not requiring intervention 
 
Statistical Analysis 
Comparisons between baseline demographics will be performed using a t-test.    To 
assess the impact of each sedation regimen on cardiovascular status, the minimum BP 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
15 
 
and HR recorded during the sedation encounter in each subject will be identified and 
the percentage decrease from corresponding baseline or pre-sedation values will be 
calculated.  Maximal percentage decrease in BP and HR between groups will be 
compared via t-test.  Induction time (time from initiation of sedation administration to 
achievement of a sedation depth adequate to start the procedure) and recovery time 
(time from procedure completion to achieving sedation monitoring discharge criteria 
(see Procedures section, number 5)) will be calculated for each patient and comparison 
of each between groups will be performed using a t-test.  Incidences of other adverse 
events (hypoxia, respiratory suppression, recovery-related emergence reactions) will be 
compared between groups using chi-squared analysis.  A p value of <0.05 will be 
considered significant. 
 
 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
16 
 
REFERENCES 
1) 
Ronchera-Oms CL, Casillas C, Marti-Bonmati L, et al.  Oral chloral hydrate provides 
effective and safe sedation in paediatric magnetic resonance imaging. J Clin Pharm 
Therap 1994;19:239-243. 
2) 
Malviya S, Voepel-Lewis T, Tait AR, Reynolds PI, Gujar SK, Gebarski SS, Eldevik 
OP. Pentobarbital vs chloral hydrate for sedation of children undergoing MRI: 
Efficacy and recovery characteristics. Pediatr Anesth 2004;14:589-595. 
3) 
Mason KP, Zurakowski D, Karian VE, Connor L, Fontaine PJ, Burrows PE. Sedatives 
used in pediatric imaging: comparison of IV pentobarbital with IV pentobarbital 
with midazolam added. Am J Roentgen 2001;177:427-430. 
4) 
Mason KP, Zurakowski D, Connor L, Karian VE, Fontaine PJ, Sanborn PA, Burrows 
PE. Infant sedation for MR imaging and CT: Oral vs intravenous pentobarbital. 
Radiology 2004;233:723-728. 
5) 
Mallory MD, Baxter AL, Kost SI and the Pediatric Sedation research Consortium. 
Propofol vs pentobarbital for sedation of children undergoing magnetic resonance 
imaging: results from the Pediatric Sedation Research Consortium. Pediatr Anaesth 
2009;19:601-611.  
6) 
Srinivasan M, Turmelle M, DePalma LM, Mao J, Carlson D. Procedural sedation for 
diagnostic imaging by pediatric hospitalists using propofol: Analysis of the nature, 
frequency, and predictors of adverse events and interventions. J Pediatr 
2012;160:801-806. 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
17 
 
7) 
Mahmoud M, Gunter J, Donnelly LF, Wang Y, Nick TG, Sadhasivam S. A 
comparison of dexmedetomidine with propofol for magnetic resonance imaging 
sleep studies in children. Anesth Analg 2009;109:745-753. 
8) 
Berkenbosch JW, Huffington D, Smith P, Hessenkemper, T. Factors affecting the 
efficacy of chloral hydrate for pediatric procedural sedation. Crit Care Med 
2005;33:259-T (abstract). 
9) 
Mason KP, Prescilla R, Fontaine PJ, Zurakowski D. Pediatric CT sedation: 
comparison of dexmedetomidine and pentobarbital. Am J Roentgenol 
2011;196:W194-198. 
10) Cravero JP, Beach ML, Blike GT, Gallagher SM, Hertzog JH and the Pediatric 
Sedation Research Consortium. The incidence and nature of adverse events during 
pediatric sedation/anesthesia with propofol for procedures outside the Operating 
Room: A report from the Pediatric Sedation Research Consortium. Anesth Analg 
2009;108:795-804. 
11) Short SM, Aun CST. Haemodynamics of propofol in children. Anaesthesia 
1991;46:783-785. 
12) Berkenbosch JW, Wankum P, Tobias JD.  A Prospective Evaluation of 
Dexmedetomidine for Non-invasive Procedural Sedation in Children.  Pediatr Crit 
Care Med 2005;6:435-439. 
13) Mason KP, Zurakowski D, Zgleszewski SE, Robson CD, Carrier M, Hickey PR, 
Dinardo JA. High dose dexmedetomidine as the sole sedative for pediatric MRI. 
Paediatr Anaesth 2008;18:403-11. 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
18 
 
14) Lubisch N, Roskos R, Berkenbosch JW. Dexmedetomidine for procedural sedation 
in children with Autism Spectrum Disorders and other neurobehavioral disorders. 
Pediatr Neurol 2009;41:88-94. 
15) Koroglu A, Teksan H, Sagir O, Yucel A, Toprak HI, Ersoy OM. A comparison of the 
sedative, hemodynamic and respiratory effects of dexmedetomidine and propofol 
in children undergoing magnetic resonance imaging examination. Anesth Analg 
2006;103:63-67.  
16) Mason KP, Zgleszewski SE, Prescilla R, Fontaine PJ, Zurakowski D. Hemodynamic 
effects of dexmedetomidine sedation for CT imaging studies. Paediatr Anaesth 
2008;18:393-402. 
17) Mason KP, Zgleszewski SE, Forman RE, Stark C, DiNardo JA. An exaggerated 
hypertensive response to glycopyrollate therapy for bradycardia associated with 
high-dose dexmedetomidine. Anesth Analg 2009;108:906-908. 
18) Tomatir E, Atalay H, Gurses E, Urbay H, Bozkurt P. Effects of low dose ketamine 
before induction on propofol anesthesia for pediatric magnetic resonance imaging. 
Pediatr Anesth 2004;14:845-850. 
19) Aouad MT, Moussa AR, Dagher CM, Muwakkit SA, Jabbour-Khoury SI, Zbeidy RA, 
Abboud MR, Kanazi GE. Addition of ketamine to propofol for initiation of procedural 
anesthesia in children reduces propofol consumption and preserves hemodynamic 
stability. Acta Anaesthesio Scand 2008;52:561-565. 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
19 
 
20) Shah A, Mosdossy G, McLoed S, Lehnhardt K, Peddle M, Rieder M. A blinded, 
randomized controlled trial to evaluate ketamine/propofol versus ketamine alone 
for procedural sedation in children. Ann Emerg Med 2011;57:425-433. 
21) Tosun Z, Akin A, Guler G, Esmaoglu A, Boyaci A. Dexmedetomidine-ketamine and 
propofol-ketamine combinations for anesthesia in spontaneously breathing 
pediatric patients undergoing cardiac catheterization. J Cardiothorac Vasc Anesth. 
2006 Aug;20(4):515-519. 
22) Mester R, Easley RB, Brady KM, Chilson K, Tobias JD. Monitored anesthesia care 
with a combination of ketamine and dexmedetomidine during cardiac 
catheterization. Am J Ther 2008;15:24-30.  
23) Canpolat DG, Esmaoglu A, Tosun Z, Akin A, Boyaci A, Coruh A. Ketamine-propofol 
vs ketamine-dexmedetomidine combinations in pediatric patients undergoing burn 
dressing changes. J Burn Care Res 2012;33:718-722. 
24) Sikich N, Leman J. Development and psychometric evaluation of the Pediatric 
Anesthesia Emergence Delirium scale. Anesthesiology 2004;100:1138-1145. 
25) Belleville JP, Ward DS, Bloor BC, Maze M. Effects of intravenous dexmedetomidine 
in humans: Sedation, ventilation and metabolic rate. Anesthesiology 
1992;77:1125-1133. 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
20 
 
Study Event Table 
Study  Event/Day 
Screening 
Baseline 
(Sedation 
Initiation) 
Sedation 
Period 
Recovery 
Period 
End of Study 
(24 hours from 
end of MRI) 
Informed 
Consent/Assent 
X 
 
 
 
 
Inclusion/Exclusion 
Criteria 
X 
 
 
 
 
Medical History & 
Demographics 
X 
X 
 
 
 
Concomitant 
Medications 
X 
X 
X 
 
 
Physical 
Examination 
X 
X 
X 
 
 
Vital Signs (BP, HR, 
RR, temperature & 
pulse oximetry) 
X 
X 
X 
 
 
AE/SAE 
 
X 
X 
 
X 
PAED Scale 
 
 
 
X 
 
 
 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
21 
 
CASE REPORT FORM  
 
 
SUBJECT #_______ 
INITIALS_____________ 
 
DOB: ____________AGE:____________years  
 
GENDER: 
 M 
 F 
 
WEIGHT:___________kg  HEIGHT: _____________cm  BMI: ______________ 
 
 
PRIMARY DIAGNOSIS:___________________________ 
 
SECONDARY DIAGNOSES:________________________________________ 
 
 ____________________________________________________________ 
 
INDICATION FOR MRI: _______________________________________ 
 
 
CURRENT MEDICATIONS: 
Drug 
Dose 
Study Start 
Date 
Indication 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
22 
 
SUBJECT #________________ 
 
INITIALS__________________ 
 
SEDATION ENCOUNTER: 
 
Induction Drugs: 
 
 
 
Study Drug: 
 
Group (A/B):______________________ 
 
 
 
 
 
 
 
 
Volume (mL)______________________ 
 
 
 
 
 
 
 
Time administered:_________________ 
 
 
Dexmedetomidine: 
 
 
 
Induction Dose: Dose given:__________mg/kg  Total Dose: _____________mg 
 
 
 
 
 
 
Time administered:_________________ 
 
 
 
Extra Doses: 
 
 
Dose given:___________________mg 
Time administered:_________________ 
 
 
 
 
 
 
Dose given:___________________mg 
Time administered:_________________  
 
Dose given:___________________mg 
Time administered:_________________ 
 
Dose given:___________________mg 
Time administered:_________________ 
 
 
 
 
 
 
 
 
 
 
 
 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
23 
 
Outcomes: 
Sedation Effective: 
 Yes 
  No 
Procedure completed: 
 Yes 
  No 
Recovery-related problems (during 24 hours post MRI): 
 Yes 
  No 
If yes, describe:___________________________________________________________________ 
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________ 
Other adverse events (during 24 hours post MRI):  
 Yes 
  No 
If yes, describe:___________________________________________________________________ 
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________ 
Induction time (min):_______________________ 
 
Recovery time (min):________________________ 
 
 
 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
24 
 
Vital Signs during Sedation/recovery: page _____ of ______ 
 
 
TIME 
RR 
HR 
SpO2 
ET-CO2 
BP 
Pain 
Score 
Sedation 
Score 
PAED 
Score 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Ketamine-Dexmedetomidine vs Midazolam-Dexmedetomidine for MRI sedation 
Version 2.0 
Date: 04/02/2014 
25 
 
Vital Signs during Sedation/recovery: page _____ of ______ 
 
 
TIME 
RR 
HR 
SpO2 
ET-CO2 
BP 
Pain 
Score 
Sedation 
Score 
PAED 
Score