Periopera(ve Management of Children With Au(sm: A Pilot Study. Dr. Desigen Reddy Dr. Leora Bernstein

Transcription

1 Periopera(ve Management of Children With Au(sm: A Pilot Study Dr. Desigen Reddy Dr. Leora Bernstein

2 Conflict of Interest

3 BACKGROUND

4 Au(sm Clinical diagnosis Males > females Equal distribu(on race, ethnicity, and SES Increasing prevalence: 2-5/10,000 to 1/88 school aged children DSM V grouped au(s(c disorder, Asperger s disorder, and PDD under Au(sm Spectrum Disorder

5 Au(sm Deficits with regards to social communica(on Restricted repe((ve paverns Repe((ve motor movement Insistence on sameness Highly restricted fixated interests Present in early childhood May or may not have intellectual disability or GDD

6 Why is an interven(on needed? Increasing numbers of children with ASD presen(ng to the OR (?2-4 a month) Require repeated general anesthe(cs for rou(ne procedures (dental, eye, lab work) due to lack of co- opera(on Distressing and dangerous to health care personnel, caregivers, and other pa(ents Causes delays and cancella(ons specifically in PACU

7 Previous Studies Van Der Walt et al 1998 pilot study at Women s and Children s Hospital South Australia on 5 children followed by an audit of 59 children (2001) over 4 years Thompson et al at Children s Medical Centre Dallas (43 pa(ents over 6 months) Dr. Joanne Schwartz at Children s Hospital in Winnipeg in process of publica(on (250 pa(ents over 3 years) Lindberg et al Skaraborg Hospital (Sweden) 12 pa(ents qualita(ve study

8 BoVom Line Lack of coopera(on: 50% in 1997, 42% in 1998, 30% in 1999 and 17% in 2000 Early recogni(on Quiet Room Pre- op seda(on- consider ketamine even in mild cases do not need IV midazolam at the end of the case- have not had problems (hard to assess, give it in cola (parents take too!) Discuss in advance possibility of restraint with parents- less uncommon as (me has gone on Parents are sa(sfied even when restraint has been used, anesthe(sts and nurses are enthusias(c Have expanded this program for other high needs children

9 A tutorial on pilot studies: the what, why and how Thabane, L. et al 2010 PILOT STUDY

10 Pilot Study You never test the depth of the water with both feet Main goal is to test feasibility prior to star(ng a larger study Very good for unchartered territory Suitable to generate data for sample size calcula(ons especially when there is no previous data

11 Sample Size Does not need to be powered but should be representa(ve of the target popula(on Same inclusion/exclusion criteria as the main study Large enough to provide useful informa(on

12 Defining Success Need specific criteria for success based on feasibility Outcome: Stop: not feasible Con(nue: with modifica(ons Con(nue: without modifica(on but monitor closely Con(nue: without modifica(ons

13 MANAGEMENT OF CHILDREN WITH AUTISM IN THE OR: PILOT STUDY

14 PICO Popula(on: All pa(ents between the ages of 3-17 with a diagnosis of Au(sm Spectrum Disorder scheduled for elec(ve surgery in the OR at MUMC who have had a previous general anesthe(c in the Opera(ng Room Interven(on: a specific care bundle designed for children with au(sm in the OR Comparison: previous experience as rated by caregiver Outcome: Feasibility

15 POPULATION

16 Inclusion All pa(ents between the ages of 3-17 with a diagnosis of Au(sm Spectrum Disorder scheduled for elec(ve surgery in the OR at MUMC who have had a previous general anesthe(c in the Opera(ng Room

17 Exclusion Criteria Caregiver declines to give consent

18 Sample Size 10 pa(ents who are seen in the pre- opera(ve clinic between January June 2014 Hypothesize 2-4 pa(ents/ month Will ensure feasibility and allow for early changes Need enough pa(ents to jus(fy need for interven(on but not too many that it is overly disrup(ve

19 INTERVENTION

20 ASD child is iden(fied and consent is obtained from caregiver Child life interviews caregivers, fills template and gives handout Pediatric anesthe(st fills out pre- printed order form for day of sx Child is booked as Special accomoda(ons by desk clerk on OR list

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26 Pa(ent admived to pre- op Same day Wai(ng room outside OR OR PACU Same day

27 Admit to same day (caregiver registers) Direct to OR PACU Home

28 Health care Providers

29 Health Care Providers Did you find these interven(ons disrup(ve to your usual rou(ne? Yes No Unsure Did you find these interven(ons beneficial to your usual rou(ne? Yes No Unsure Would you con(nue this interven(on? No Yes Yes with the following modifica(ons: Comments:

30 Caregivers: Rate your OR experience (previous and current) pleasant acceptable difficult. extremely distressing. 1. Did you fill out a pre- op template with child life and anesthesia? 2. Did the staff make reference to having reviewed the informa(on? 3. What did you find helpful? 4. What would have been more helpful? 5. Did your child have difficul(es? What helped and what do you wish the staff did at that (me?

31 OUTCOMES

32 Feasibility Outcomes Able to enroll 10 pa(ents over a 6 month period Able to collect data Adherence to protocol 90% follow up with parents

33 Defini(ve Trial Outcomes Primary: comparison of anesthe(c + interven(on to previous anesthe(c Secondary: Descrip(ve sta(s(cs of this popula(on (type of surgery, comorbidi(es, age and weight) Time from admission to surgery and (me from PACU to discharge Pre- opera(ve seda(on success rates : Seda(on scale 1-3 Emo(onal state 1-2 Qualita(ve data- caregiver percep(on of staff knowledge of au(sm, feelings and experiences peri- op

34 References Van der Walt, J.H., Moran, C. (2001). An Audit of Periopera(ve Management of Au(s(c Children. Pediatric Anesthesia 2001 ; Thompson, D.G., Tielsch- Goddard, A. (2014) Improving Management of Pa(ents with Au(sm Spectrum Disorder Having Scheduled surgery: Op(mizing Prac(ce. Journal of Pediatric Health Care 2014; 28 (5): Bagshaw,M. Aneasthesia and the au(s(c child.journal of Periopera8ve Prac8ce ; 21 (90) Lindberg,S., von Post, I., Eriksson,K. The experience of parents of children with severe au(sm in connec(on with their children s anesthe(cs, in the presence and absence of the periopera(ve dialogue: a hermeneu(c study. Scandinavian Journal of Caring Sciences 2012; 26 (4): Souders, M.C., et al. Caring for Children and Adolescents with au(sm who require challenging procedures. Pediatric Nursing (6); Delli K, Reichart PA, Bornstein, MM, Livas, C. Management of children with au(sm spectrum disorder in the dental sevng: Concerns, behavioural approaches and recommenda(ons. Med Oral Patol Oral Cir Bucal Nov 1; 18(6) Gutstein,H., Johnson,K., Heard,M., Gregory,G.Oral Ketamine Preanesthe(c Medica(on in Children.Anesthesiology. 1992; 76 (1): Benedikt,T, Rzepecki,A., Sauer,K., Hobbhahn,J. A comparison of two different doses of ketamine with midazolam and midazolam alone as oral preanesthe(c medica(on on recovery awer sevoflurane anesthesia Pediatric Anesthesia. 2002; 12: Warner DL, Cabaet J, Velling D. Ketamine plus midazolam a most effec(ve paediatric premedicant. Pael Aneasth 1995; 5: Feld, L.H., Negus J.B., White P.F. Oral midazolam preanesthe(c medica(on in pediatric outpa(ents Anesthesiology , Moore P, Cuddy M, Magera J, Caputo, A, Chen A, Wilkinson L. Oral transmucosal fentanyl pretreatment for outpa(ent general anesthesia Anesth Prog :29-34 Nishina K, Mikawa K. Clonidine in Pediatria Anesthsia Curr Opin aneathesiol 15: Bevan JC, Veall GR< Macnab AJ et al. Midazolam premedica(on delays recovery awer propofol without modifying involuntary movements. Anesth analg 1997; 85: Viitanen H, Annila P, Viitanen M et al. Premedicatoin with Midazolam delays recovert from propofol induced sevoflurane anesthesia in children 1-3 r. Can J Anaesth 1999; 46: Binstock, W. Rubin, R, Bachman, C, Kahan M, et al. The effect of premedicatoin with OTFC with or without ondansetron on postopera(ve agita(on and nausea and com(ng in pedatric ambulatory pa(ents. Pediatric anesthesia 2004 ; 14: Thabane L, Jinhu, et al. A tutorial on pilot studies: the what why and how. Medical Research Methodology :1 hvps://

35 QUESTIONS?

36 J. H. Van Der Walt and C. Moran AN AUDIT OF PERIOPERATIVE MANAGEMENT OF AUTISTIC CHILDREN

37 87 anesthe(cs to 59 children over 4 years Pa(ent iden(fied on PaedRAP a database with recurrent anesthe(c issues- alerts Anesthesia department Conducted a telephone interview by an anesthe(st- filled out a ques(onniare Direct admission to day surgery 45 minutes prior to surgery Oral midazolam 0.5 mg/kg for mild and ketamine 7 mg/kg 30 minutes prior to procedure IM ketamine 5 mg/kg when oral premedica(on refused Mixed in a favorite clear fluid as per list (lemonade, cola, or apple juice)

38 IV or inhala(onal induc(on IV fluids and tropisetron used prophylac(cally Given oral (prior to surgery) or rectal tylenol Adequate analgesia Child is recorded as coopera(ve or uncoopera(ve by anesthe(st PONV episodes recorded Nursing notes examined Anesthe(c record filed in Au(s(c registery

39 Results

40 Results (cont)

41 Pilot study Grouped under: Process: process key to the success of the main study Resources: assessing (me and resource issues that can arise in the main study Management: personnel and data management Scien(fic: treatment safety, dose levels and response