4/18/14. Background. Evaluation of a Morphine Weaning Protocol in Pediatric Intensive Care Patients. Background. Signs and Symptoms of Withdrawal

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1 Background 1 Evaluation of a Morphine Weaning Protocol in Pediatric Intensive Care Patients Alyssa Cavanaugh, PharmD PGY1 Pharmacy Resident Children s Hospital of Michigan **The speaker has no actual or potential conflict of interest in relation to this presentation** 2 Long-term opioid infusions are needed for intensive care unit (ICU) patients to manage pain Sedation used to prevent Accidental self-extubation Catheter removal Reduce morbidity associated with inadequate management of distress Can J Hosp Pharm Vol 65(1):12-18 Background Signs and Symptoms of Withdrawal Withdrawal: Clinical syndrome that manifests after stopping or reversing a drug after prolonged exposure Primary Mechanism Opioid receptor coupling to Gs protein Superactivation of camp pathway Activation of excitatory amino acid receptors 3 Categories of Symptoms CNS irritability GI dysfunction Autonomic dysfunction Anxiety Agitation Tremors Seizures Vomiting Diarrhea Poor feeding Fever Sweating High blood pressure Yawning 3 Pediatrics Vol 125:e1208-e Can J Hosp Pharm Vol 65(1):12-18 Learning Question #1 Which of the following are signs and symptoms of opioid withdrawal? A. Tremor B. High blood pressure C. Vomiting D. All of the above Withdrawal Assessment Withdrawal is a common side effect of prolonged sedation in a pediatric intensive care unit (PICU) Method of assessment and monitoring is warranted Withdrawal Assessment Tool-1 (WAT-1): evaluates withdrawal symptoms in a PICU setting 5 6 Pediatr Crit Care Med Vol 9(6):

2 Withdrawal Assessment Withdrawal Assessment Tool-1 Validity and generalizability of the Withdrawal Assessment Tool-1 (WAT-1) for monitoring iatrogenic withdrawal syndrome in pediatric patients Purpose Conclusion To investigate the validity and generalizability of the Withdrawal Assessment Tool-1 (WAT-1) in children during weaning of analgesics and sedatives All subjects exposed to 5 or more consecutive days of opioids had been assessed for withdrawal symptoms twice daily at 8 am and 8 pm (and at other times if clinically indicated) from the day that opioid weaning started until 72 hours after last opioid dose 308 children throughout 22 centers Higher WAT-1 scores (> 3) had a longer PICU length of stay than those with WAT-1 scores (<3) WAT-1 demonstrated feasibility and utility as evidenced by its successful implementation and use by nurses in major pediatric centers across the USA WAT-1 shows good generalizability when used to assess clinically important withdrawal symptoms in the PICU 7 Pain 2012 January. Vol 153(1): Pain 2012 January. Vol 153(1): Opioid Pharmacokinetics Half-life Learning Question #2 What is the half-life of oral morphine? A hours B hours C hours D. All of the above 9 Am J Dis Child August. Vol 146: Previous Studies Study Rationale Children s Hospital of Michigan Historical Controls (unpublished data) January 1st, 2010 to September 30th, 2012 October 1st, 2012 to March 1st, Methadone wean Retrospective n=64 Average wean: days (1-111) Average rescue doses: 42 doses/wean (0-695) Average cost/wean: $4.52 ( ) Longer weans Multiple rescue doses needed during wean Morphine 2-arm wean (10 day and 20 day) Prospective n=24 Average wean: 8.75 days (2-19) Average rescue doses: 3.3 doses/wean (0-15) Average cost/wean: $3.15 ( ) Patients finished wean faster than allotted time WAT-1 scores were not accurately recorded or lack of recordings 12 2

3 Purpose Evaluation of a Morphine Weaning Protocol in Pediatric Intensive Care Patients Describe the incidence of opioid withdrawal in pediatric patients using a 3-arm morphine weaning protocol Primary investigator: Alyssa Cavanaugh, PharmD Secondary investigators: Joanna Ditouras, PharmD, Kevin Valentine, MD Children s Hospital of Michigan Detroit Medical Center Study Outcomes Primary Outcome Incidence of opioid withdrawal in pediatric patients Secondary Outcomes Identify adherence to protocol Compare the duration of medication therapy and cost Compare the length of ICU stay All patients were placed in a wean protocol if they had been on continuous infusion morphine for > 5 days # of Infusion Days Wean 5-10 days 5 day Patients were divided into 3 different groups 5 day wean 10 day wean 15 day wean days 10 day > 16 days 15 day

4 Calculate the Original Daily Dose (ODD) Morphine Oral (mg) ODD= 2X (Total of IV bolus + infusion from previous day) Example: 10 kg pt Infusion: 40 mcg/kg/hr Bolus: 0.4 mg IV q2hr = 6 bolus/24hrs Day 5 DAY MORPHINE WEAN Original Daily Dose (ODD)= 2X(Total of IV bolus+infusion from previous day) 1 Divide ODD every 6 hours 2 Decrease to 80% of ODD and divide every 6 hours 3 Decrease to 60% of ODD and divide every 8 hours 4 Decrease to 40% of ODD and divide every 12 hours 5 Decrease to 20% of ODD and divide every 12 hours 6 Discontinue morphine 23 Day 10 DAY MORPHINE WEAN Original Daily Dose (ODD)= 2X(Total of IV bolus+infusion from previous day) 1 Divide ODD every 4 hours 2 Decrease to 90% of ODD and divide every 4 hours 3 Decrease to 80% of ODD and divide every 6 hours 4 Decrease to 70% of ODD and divide every 6 hours 5 Decrease to 60% of ODD and divide every 8 hours 6 Decrease to 50% of ODD and divide every 8 hours 7 Decrease to 40% of ODD and divide every 12 hours 8 Decrease to 30% of ODD and divide every 12 hours 9 Decrease to 20% of ODD and give every 12 hours 10 Decrease to 10% of ODD and give every 12 hours 11 Discontinue morphine 15 DAY MORPHINE WEAN Day Original Daily Dose (ODD)= 2X(Total of IV bolus+infusion from previous day) 1 Divide ODD every 4 hours WAT-1 scoring from the 1st day of wean 2 Decrease to 90% of ODD and divide every 4 hours 3 no change 4 Decrease to 80% of ODD and divide every 6 hours 5 Decrease to 70% of ODD and divide every 6 hours Scored twice daily (once per nursing shift) 6 no change 7 Decrease to 60% of ODD and divide every 8 hours 8 Decrease to 50% of ODD and divide every 8 hours Continued until 72 hours after the last dose 9 no change 10 Decrease to 40% of ODD and divide every 12 hours 11 Decrease to 30% of ODD and divide every 12 hours 12 no change 13 Decrease to 20% of ODD and divide every 12 hours 14 Decrease to 10% of ODD and divide every 12 hours 15 no change Discontinue morphine 25 4

5 Rescue Dose If patients received 3 or more doses for breakthrough in a 24 hour period with appropriate WAT-1 score confirmation, then patients were moved back by 2 days Example: A child on day 3 of a wean received 3 breakthrough (not counting for pain or procedures) doses of morphine with confirming WAT-1 scores, then go back to day 1 of protocol Statistical Analysis Descriptive statistics were used to: Evaluate demographic and visit characteristics Identify incidence of withdrawal Identify adherence to protocol Describe the duration of therapy, cost, and length of ICU stay Background Demographics Primary Outcome: Incidence of opioid withdrawal in pediatric patients WAT-1 scores # of rescue doses/wean Adherence to Protocol 30 WAT-1 Scores 100% had at least one WAT-1 78% had a daily WAT-1 56% had a twice daily WAT-1 Rescue Doses 14 total doses (0.52 doses/wean) 9/14 had a documented WAT-1 > 3 and gave rescue dose 4/14 described signs and symptoms of withdrawal and gave rescue dose 1/14 had rescue dose given with no signs and symptoms or WAT-1 score 31 5

6 Confounders Secondary outcomes Duration of medication therapy Continuous infusion Average = 10.2 days (4-40) Taper Average = 9.52 days (4-25) Cost of therapy Average = $7.97/wean ( ) Length of ICU stay Average = 32.3 days (9-148) Length of hospital stay Average = 36.1 days (12-148) Discussions Morphine comparisons Outcomes Length of continuous infusion Duration of medication therapy (Historical Controls) October 1st, 2012 to March 1st, 2013 (Current Data) October 1st, 2013 to March 1st, days (5-23) 10.2 days (4-40) 8.75 days (2-19) 9.52 days (4-25) # of morphine doses doses (4-78) doses (8-73) Cost of therapy $3.15 ( ) $7.97 ( ) Length of ICU stay 21 days (8-44) 32.3 days (9-148) Conclusions 67% adherence to protocol Cardiovascular patients had longer weans than those admitted for a respiratory diagnosis Better compliance for completion of WAT-1 scores by PICU staff 93% rescue doses given were addressed either through WAT-1 score or described signs and symptoms Conclusions Limitations Compared to 2-arm wean Small study, n = 27 Single center Excluded patients on high dose opioid infusions WAT-1 is a subjective scale assessed by multiple RNs in PICU and floor Patients transferred to floor Patients discharged prior to wean finishing

7 Future Directions WAT-1 scores to be incorporated on flow sheets for PICU and EMR for floor patients Formal teaching will be expanded beyond PICU to floor teams and nurses Evaluate if a cardiovascular specific wean needs to be created Evaluate if high WAT-1 scores on day 1 require an increased ODD or a move up to next wean category Acknowledgements Dr. Joanna Ditouras, PharmD and Dr. Kevin Valentine, MD Children s Hospital of Michigan PICU staff Selmir Mahmutovic, PharmD Candidate 2015 and Matthew Duprey, PharmD Candidate Evaluation of a Morphine Weaning Protocol in Pediatric Intensive Care Patients 40 Alyssa Cavanaugh, PharmD Children s Hospital of Michigan Detroit Medical Center 7