Disclosure. Case. Objectives. Definition of Pediatric Pain. Pediatric Pain: Misunderstood. "Ow, Mommy it Hurts!" Managing Pediatric Pain 7/25/2013

Transcription

1 47 th Annual Meeting August 2-4, 2013 Orlando, FL "Ow, Mommy it Hurts!" Managing Pediatric Pain Tara McCabe, Pharm.D. Pediatric Hematology/Oncology Clinical Pharmacy Specialist UF Health Shands Children s Hospital Gainesville, Florida Disclosure I do not have a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation 2 Objectives Upon completion of this activity, the participant should be able to: Identify challenges in managing pediatric pain Develop strategies for the safe and effective use of patient controlled analgesia (PCA) in children Discuss prior authorization requirements for pediatric oxycodone Case EM is a 5 year old M, wt 20 kg, with Stage IV high risk neuroblastoma with refractory disease and tumor progression. He is on home hospice admitted to the hospital today for fever and neutropenia Home pain meds: Morphine 2 mg (0.01 mg/kg) IV q4h scheduled Morphine liquid 2 mg (0.01 mg/kg) PO q4h prn breakthrough pain Antibiotics started on admission: Cefepime 1000 mg (50 mg/kg) IV q8h 3 4 Definition of Pediatric Pain An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage. International Association for the Study of Pain The inability to communicate verbally does not negate the possibility that an individual is experiencing pain and is in need of appropriate pain relieving treatment. International Association for the Study of Pain Pediatric Pain: Misunderstood Children require primarily behavioral treatment for pain only Neonates are physiologically unable to perceive pain Inexperience Wickham Kraemer F. Semin Pediatr Neurol 2010; 17: Franson HE. AANA 2010;78(5):

2 Multi dimensions of Pain Sensory Physiological Cognitive Affective Behavioral Spiritual Classification Pathophysiologic Nociceptive vs Neuropathic Pain duration Acute vs Chronic Episodic vs Recurrent Etiology Malignant vs Non malignant Anatomical Location vs Function Acute vs. Chronic Pain Epidemiology Acute Less than 30 days Symptoms/causes overlap Sudden onset Felt immediately following injury Severe intensity Short lasting Chronic Greater than 3 months Symptoms/causes overlap Continuous/recurrent Absence of pathophysiology Negatively affect all aspects of daily life 25% of children have experienced pain in the past 3 months 6 8% of children reported intense and frequent pain Children with chronic pain frequently miss long periods of school and have difficulty maintaining social contacts and development Families of children are affected due to missed work days Increasing evidence that chronic pain childhood may lead to chronic pain as an adult World Health Organization 2012 Slover R, Neuenkirchen GL Olamikan S, et al. Advances in Pediatrics 2010; 57: Goddard JM. Curr Opin Support Palliat Care 2011; 5: Assessing Pain Initial Pain Assessment Detailed pain history Physical exam Diagnosis of the causes Measurement of pain severity using an ageappropriate pain measurement tool 11 World Health Organization

3 Children s Expression of Pain Behavioral Indicators Children unable to talk dependent on parents/caregivers observation of behavior 2 4 year old ability to indicate presence of pain verbally Gradually learn three levels of pain a little, some and a lot 5 year old children can describe pain and define its intensity 6 year old clearly differentiate the levels of pain and define its intensity 7 10 year old can explain why it hurts World Health Organization 2012 Acute Facial expression Body movement and posture Inability to be consoled Crying Groaning Chronic Abnormal posturing Fear of being moved Lack of facial expression Lack of interest Undue quietness Increased irritability Low mood Sleep disruption Anger Changes in appetite Poor school performance Pain Intensity Tools No single pain intensity tool is appropriate for all age groups or all pain types Need to be able to quantify pain Tools have been developed for: Cognitively impaired Unable to talk Critically ill Faces Pain Scale 4 12 years Self report Simple, quick to use Available in 47 languages Easy to administer and reproducible Free Links/FacesPainScaleRevised/default.htm 16 Pieces of Hurt Tool Visual Analog Scale 3 12 years Self report Poker Chip Tool Concrete ordinal rating scale Weakness Cleaning chips between patient use Limited number of response options (0 4) Modest evidence of reliability and validity in 3 4 year old Available in Arabic, English, Spanish, Thai 17 Above 8 years of age Self report Correlates significantly with parent/caretaker ratings Recall bias Requires high degree of abstraction Chinese, English, French, Italian, Nigerian languages, Portuguese, Spanish Free 1.pdf 18 3

4 The Oucher 3 12 years Color photographic scale African American, Asian, Caucasian, Hispanic Requires color printing Numerical 0 10 Rating Scale Above 8 years of age Self report Requires child to verbally estimate pain English umericratingscale.pdf FLACC Non verbal Face, Legs, Activity, Cry, Consolability Total points 0 10 Inter rater variability scores Pain Management Pain Ladder Two Step Approach Severe Strong Opioid Moderate Severe Strong Opioid Mild Acetaminophen/Ibuprofen

5 Elimination of Weak Opioids Tramadol Insufficient evidence in pediatrics Codeine CYP2D6 metabolism Children less than 5 years old have ~25% of adult value of CYP2D6 enzyme activity Poor metabolizers range 1 30% based on ethnicity Ultra rapid metabolizers and new FDA boxed warning CYP 2D6 Ultra Rapid Metabolizers (UM) Dosing in Opioid Naïve Pediatric Patients (1 12 years) Population Prevalence % (UM/Total n) African/Ethiopian 29% (35/122) African American 3.4% (3/87) 6.5% (60/919) Asian 1.2% (5/400) Caucasian 3.6% (33/919) 6.5% (18/275) Greek 6% (17/283) Hungarian 1.9% Northern European 1 2% Medication Route of administration Starting Dose Morphine Oral (immediate release) 1 2 years: mcg/kg every 4 hours 2 12 years: mcg/kg every 4 hours (max 5 mg/dose) IV injection 1 2 years: 100 mcg/kg every 4 hours 2 12 years: mcg/kg every 4 hours (max 2.5 mg) IV infusion mcg/kg, then mcg/kg/hr Dosing in Opioid Naïve Pediatric Patients (1 12 years) Adapting Treatment to Individual Child Medication Route of administration Starting Dose Fentanyl IV injection 1 2 mcg/kg, repeat every min IV infusion 1 2 mcg/kg, then 1 mcg/kg/hr Hydromorphone Oral (immediate release) mcg/kg every 3 4 hours (max 2 mg/dose) IV injection 15 mcg/kg every 3 6 hours Oxycodone Oral (immediate release) mcg/kg every 4 hours (max 5 mg/dose) No specific or maximum dose of opioids Best possible pain relief with acceptable side effects Dose at regular intervals By the clock Oral administration is preferred Liquid vs tablet Avoid intramuscular injections

6 When is a PCA Appropriate? Patient Controlled Analgesia (PCA) Combination of age, cognitive ability, and physical ability Children over 7 years Have understanding of the relationship among pain, pushing the button, and pain relief Ability to verbalize increasing or decreasing pain Definitions PCA: Patient controlled analgesia PCA by proxy: Patient controlled analgesia by parent/caregiver PNCA: Parent nurse controlled analgesia PCA Use in Pediatric Cancer Patients Safety and efficacy of PCA use over a 48 hour observation period 18 children (6 15 years) Moderate to severe pain Treated with fentanyl 1 mcg/kg/hr plus bolus 1 mcg/kg with lock out 7 min Monitoring: respiratory rate, pulse oximetry, heart rate, blood pressure Pain assessed: affective facial scale (AFS) and visual analog scale (VAS) PCA efficacy and patient compliance questionnaire 33 Ruggiero A, Barone G, Liotti L, et al. Support Care Cancer (2007) 15: Results in Pediatric Cancer Patients Pain scores and vital signs improved within 4 hours of treatment and remained constant Average total dose of fentanyl delivered 16.3 μg/kg (range , median 10.9) Each patient self administered 9.9±4.9 boosters (range 6 25) Side effects occurred in 7 patients (39%) Itchiness, vomiting, rash Major adverse effects were not observed Questionnaire showed high level of patient satisfaction 15/18 children answered positively to all 7 questions Advantages for Cancer Patients Better analgesia during sleep wake cycles and patient movement No need for intramuscular injections Low rate of complications Overall satisfaction with pain control Increased autonomy Ruggiero A, Barone G, Liotti L, et al. Support Care Cancer (2007) 15:

7 Postoperative PCA Use Results of Postoperative PCA Use PCA group (n=21): 20 mcg/kg, lock out 5 min, background infusion of 5 mcg/kg/hr Continuous morphine (n=12): mcg/kg/hr Could increase by 10 mcg/kg/hr and give boluses of 10 mcg/kg when required Monitoring: Continuous monitoring respiratory function, sedation (four point sedation scale), pain at rest using VAS Recorded every 3 hours oxygen saturation hourly Duration of morphine treatment (h) Morphine dose on day 1 (mg/kg) Morphine dose on day 2 (mg/kg) Time Spent in the Intensive Care Unit (h) PCA Group 42 (9 52) 44 (19 59) Continuous Infusion Group 0.58 ( ) 0.52 ( ) 0.3 ( ) 0.33 ( ) 10.5 (3 21) 17 (5 24) Rugyte DC, Kilda A, Karbonskiene A. Pediatr Surg Int (2010) 26: Rugyte DC, Kilda A, Karbonskiene A. Pediatr Surg Int (2010) 26: Pain Scores at Rest Adverse Effects Variable PCA Group Continuous Infusion Group SpO (93 100) 97 (94 100) Sedation 1 (0 1) 1 (0 2) Oxygen therapy required 3 (14.3%) 3 (25%) Duration of oxygen therapy (h) 3 (1 3) 4 (1 6) Nausea/Vomiting 10 (47.6%) 2 (16.7%) Urinary retention 4 (19%) 2 (16.7%) Rugyte DC, Kilda A, Karbonskiene A. Pediatr Surg Int (2010) 26: Rugyte DC, Kilda A, Karbonskiene A. Pediatr Surg Int (2010) 26: Postoperative Pain Relief Results Postoperative Pain Relief Evaluated safety and efficacy of fentanyl PCA and midazolam infusion after neurosurgical procedure Prospective 16 children, years Fentanyl PCA pump: 1 mcg/kg with a 7 minute lockout Midazolam infusion: 2 mcg/kg/min Monitored: pulse oximetry, heart rate, respiratory rate, blood pressure, pain scores (AFS, VAS, Children s Hospital of Eastern Ontario Pain Scale) Questionnaire regarding patient compliance Statistically significant reduction in vital signs Average total fentanyl dose: 16.3 mcg/kg Self administered doses: /16 (25%) experienced minor side effects Chiaretti A, Genovese O, Antonelli A, et al. Childs Nerv Syst. 2007;24(1): Chiaretti A, Genovese O, Antonelli A, et al. Childs Nerv Syst. 2007;24(1):

8 Advantages for Postoperative Pain Relief Patient satisfaction Decreased delay between requesting analgesia and delivery Autonomy PCA by Proxy Proxy: A person authorized or designated by the institution to for another PCA by proxy: Someone other than the patient activates an analgesic infusion pump Joint Commission 2004 Sentinel Event 6,069 PCA errors 460 resulted in fatalities or some level of harm to the patient 15 of 460 were PCA by proxy errors 12 cases attributed to family member, 2 to nurse, 1 to pharmacist 1 of 15 errors was fatal The Joint Commission Sentinel Event Alert 2004; The Joint Commission Sentinel Event Alert 2004; Joint Commission Recommendations Transitioning Patients to Oral Opioids Develop criteria for selecting appropriate patients to receive PCA and nurse controlled analgesia Carefully monitor patients Teach patients and family members about the proper use of PCA and the dangers of others pressing the button for the patient Alert staff to the dangers of administering a dose for the patient outside of a nurse controlled analgesia protocol Consider placing warning tags on all PCA delivery pendants that state Only the patient should press the button Calculate total daily basal rate and convert to extended release opioid with immediate release opioid for breakthrough pain If only using intermittent IV opioid change to oral opioid as needed for pain Transitioning to oral opioids and if patient tolerates this will prove patient can be discharged home The Joint Commission Sentinel Event Alert 2004;

9 Oxycodone Prior Authorization June 7 th 2012 Florida Medicaid requires prior authorization for all single ingredient oxycodone products for patients under the age of 18 years Liquid Immediate release tablet Extended release tablet This was instituted due to parents using their child s prescriptions to obtain oxycodone for illicit drug use Drugs & Therapy Bulletin July 2012; 26(7):1 49 Drugs & Therapy Bulletin July 2012; 26(7):1 50 Oxycodone Prior Authorization Process Conclusion Prior authorization can take up to 48 hours Oxycodone is Schedule II so will be problematic for patient to receive alternative if prescriber is not aware of the prior authorization process No restriction on other schedule II opioids No restriction on oxycodone containing combination products Watch daily amount of acetaminophen administered Pediatric pain management is still evolving and there is a need for more studies and education of providers Education is needed when choosing a pain assessment tool based on age, mental status, etc PCA is an appropriate method for pain relief in pediatric patients PCA by proxy is not recommended and nurse controlled analgesia is appropriate if policy is instituted Education and awareness of Medicaid prior authorization for oxycodone is needed Drugs & Therapy Bulletin July 2012; 26(7): Questions 53 9