Renee Vicari RN, BSN, CCRN, SRNA Oakland University/Beaumont Hospital

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. (2011). Dexmedetomidine as a pediatric anesthetic premedication to reduce anxiety and to deter emergence delirium. AANA Journal, 79(3), 219-224.

3. Introduction • Published in the June 2011 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

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

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

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-0.2-0.7mcg/kg/hr • Minimal respiratory depression • Adverse effects: • N/V • Bradycardia • Hypotension • Fever

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.

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