1. Dexmedetomidine as a Pediatric Anesthetic Premedication to Reduce Anxiety and to Deter Emergence Delirium
Renee Vicari RN, BSN, CCRN, SRNA
Oakland University/Beaumont Hospital
Graduate Program of Nurse Anesthesia

2. Mountain, BW. , Smithson, L. , Cramolini, M. , Wyatt, TH. , Newman, M
Mountain, BW., Smithson, L., Cramolini, M., Wyatt, TH., Newman, M. (2011). Dexmedetomidine as a pediatric anesthetic premedication to reduce anxiety and to deter emergence delirium. AANA Journal, 79(3),

3. Introduction
Published in the June issue of American Association of Nurse Anesthetists (AANA) Journal.
Study was approved by both an affiliated university and the hospital institutional review board.

4. Key Terms!
Emergence Delirium (ED)- is a mental disturbance common in children during recovery from general anesthesia.
Symptoms:
Combative movements
Thrashing, excitability
Disorientation
Inconsolable crying
Studies also report that the incidence of ED in children ranges from 20-30%.
Why is this important to us as anesthesia providers? During ED, children risk injuring themselves by dislodging IV tubes or drains, bleeding from OR site, hurting themselves or others and increasing their pain level.

5. Purpose of Study
To compare the effects of oral dexmedetomidine and midazolam in reducing anxiety and ED in children aged 1 to 6 years receiving dental restoration.

6. Review of Literature
Kain and colleagues reported that pre-operative anxiety may be linked to emergence delirium.
54% of their subjects had negative behavior patterns at 2 weeks and 20% of these continued for up to 6 months.
Follow-up study found that children with pre-operative anxiety had a higher excitement score in PACU and negative behaviors at home.
Bad dreams
Waking up crying
Separation anxiety
Temper tantrums

7. Review of Literature
Sevoflurane, perioperative medications and pain increase ED.
Midazolam most common medication used pre-op to reduce anxiety.
Dexmedetomidine IV shown to reduce ED when given intraoperative.
Limited studies on dexmedetomidine use in children
Restricted to IV use
Dexmedeteomidine shows promise as a medication to reduce anxiety and potentially reduce the occurrence or severity of ED.

8. Hypothesis 2 Part Hypothesis:
Oral dexmedetomidine is as effective as midazolam in reducing anxiety, as measured by tool assessing separation from parent and acceptance of mask, prior to surgery.
Oral dexmedetomidine reduces the incidence and severity of ED in pediatric population.

9. Study Randomized Prospective Double-blinded design
Children were recruited to participate in this study by receiving a packet of information once their dental restoration surgical procedures were scheduled.
Families who received the information were contact by phone to determine their interest in the study and to help answer any questions regarding the study.

10. Inclusion Criteria Included 41 children Aged 1 to 6 years old
Undergoing dental restorations and possible tooth extraction.

11. Exclusion Criteria Known allergies to midazolam and or dexmedetomidine
Developmental delay or mental retardation-as reported by the parents
History of ED
ASA classification greater than II
Any previous reactions to anesthesia

12. Methods Obtained informed consent
Subjects were randomly assigned to 1 of 2 groups
Control group:
Received 0.5mg/kg of oral midazolam
Experimental group:
Received 4mcg/kg of oral dexmedetomidine
Staff and members of research team blinded to assignments and medication administered.

13. Methods Both medications were prepared in similar syringes
Prepared with cherry-flavored syrup

14. Dexmedetomidine (Precedex)
Non-selective alpha-2 adrenergic agonist
Sedative and opioid sparing effects
Expensive-$495.79
IV infusion mcg/kg/hr
Minimal respiratory depression
Adverse effects:
N/V
Bradycardia
Hypotension
Fever
In the heart, alpha agonists decrease tachycardia through the block of the cardioaccelerator nerve and produce bradycardia through the vagomimetic action. In the peripheral vasculature, there are both vasoldilatory action through sympatholysis and vasoconstriction by direct action on the alpha adrenceptors on smooth muscle cells.

15. Midazolam (Versed) Benzodiazepine Amnestic and anxiolytic properties
0.5mg-1.0mg/kg PO in children
Adverse effects:
Headache
Drowsiness
Confusion
N/V
Blood pressure changes

16. Instruments 3 instruments used
Parental Separation Anxiety Scale (PSAS) -4 point scale
1=easy separation
2=whimpers, but is easily reassured, not clinging
3=cries and cannot be easily reassured, but not clinging to parents
4=crying and clinging to parents
PSAS of 1-2 acceptable
PSAS of 3-4 were difficult separations

17. Instruments
Mask Acceptance Scale (MAS)-ability to accept the anesthesia mask
MAS scale is a 4-point Likert scale
1=excellent (unafraid, cooperative, accepts mask readily)
2=good (slight fear of mask, easily reassured)
3=fair (moderate fear of mask, not calmed with reassurance)
4=poor (terrified, crying, or combative)
Score of 1-2 was satisfactory
Score of 3-4 was unsatisfactory

18. Instruments Pediatric Anesthesia Emergence Delirium Scale (PAEDS)
Based on 5 criteria:
Makes eye contact with caregiver
Actions are purposeful
Aware of his or her surroundings
Restless
Inconsolable
Out of 20 points, a score greater than 10 indicates ED.
All research members were trained on data collection and how to score each tool to ensure interrater reliability of rating scales.

19. Data Analysis
Pearson X2 analysis was performed to determine differences between both groups for anxiety
Independent sample t test was used to determine differences between occurrence and severity of ED in both groups.
Level of significance was set at P=0.05

20. Procedures Study medication administered 30 minutes prior to OR
Pulse oximetry and blood pressure monitored every 15 minutes
Research team member accompanied child to surgery and the PSAS was scored at this time-30 minutes after child received medication
In OR with nurse anesthetist, team member calculated the MAS score

21. Procedures Study anesthesia protocol:
Mask induction with sevoflurane and nitrous oxide
Isoflurane used for maintenance
Spontaneous ventilation was maintained if possible
Muscle relaxants were avoided, if possible, if ventilatory support needed.
Anticholinergic drugs were avoided
Odansetron (0.2mg/kg) and dexamethsone (0.25mg/kg) were administered
Fentanyl for analgesia (1 to 2 mcg/kg)
Local anesthestic per surgeon

22. Procedures Taken to PACU after surgery Observed for 1 hour
PAEDS score was determined once child aroused or peak of ED

23. Results 41 subjects recruited between May 2006 and June 2007
21 (51%) males
20 (49%) females
Mean age 4 years old
27 (65%) white
9 (22%) African American
5 (12%) Hispanic

24. Results
No difference in mean blood pressure values in the 2 groups (t=0.852, P=0.399)
No difference in the pulse oximetry values in the 2 groups (t=0.459, P=0.649)
No difference in separation from parents between the 2 groups (X2=0.478, P=0.489)
No statistically significant differences between the 2 group with acceptance of the anesthesia mask (X2=0.602, P=0.438)

25. Results

26. Results Out of 41 subjects
8 children (20%) experienced ED
3 of the 8 were in the experiemental (dexmedetomidine) group
5 were in the control (Midazolam) group
No significant difference between the 2 groups (t=1.023, P=0.313)

27. Discussion
Study was able to demonstrate that 4mcg/kg PO of dexmedetomidine resulted in no adverse effects
No difference between the midazolam and dexmedetomidine groups in blood pressure or oxygenation stability

28. Strengths Double-blinded study All subjects remained in study
Equal number of males and females
Detailed and precise anesthesia protocol while child is anesthetized
Specific surgery-all subjects underwent same surgery

29. Limitations Limited sample size
Absence of fluctuations in blood pressure and heart rate (common side effect) with dexmedetomidine may indicate that 4 mcg/kg was too low to be clinically effective.
Used oral dexmedetomidine instead of buccal
Bioavailability is 16% (oral) compared to 82% (buccal)

30. Conclusion Not FDA approved for children….yet
More studies needed to examine child-friendly dexmedetomidine preparations and its effect on ED