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An Unexpected Post-op Complication Andy Fox Principal Pharmacist, Southampton University Hospitals NHS Trust. An Unexpected Post-op Complication. Andy Fox Principal Pharmacist – Risk Tamsin Griffiths SpR Paediatrics. Introduction. Case Presentation Root cause analysis Learning. Day 1.
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An Unexpected Post-op Complication Andy Fox Principal Pharmacist, Southampton University Hospitals NHS Trust
An Unexpected Post-op Complication Andy Fox Principal Pharmacist – Risk Tamsin Griffiths SpR Paediatrics
Introduction • Case Presentation • Root cause analysis • Learning
Day 1 • 4yr old boy, 16.6kg • Admitted 6/2/09 am • Vomiting, abo pain? Bladder spasm • Catheterised, bladder scan - Oxybutinin • In CRF - renal dysplasia and Reflux • eGFR 20ml/min/1.73m2
The case progresses (Day 1) • 2230hrs On-going pain & spasms • Written up for Baclofen 10mg tds by surgical reg • Dose at 23.00 and again at 06:00
Day 2 • 1200hrs – lethargic - Baclofen stopped • Gradual deterioration • 16.30 Fluctuating Conscious level • Imp • ?sepsis, ?intracranial pathology ?drug reaction/ toxicity • Transferred to PICU & intubated • CT scan – Normal • Baclofen Toxicity
Further progress • Labile BP • HF considered to reduce drug levels but appeared to be improving • Ventilated for 46hrs • Subsequent good recovery, normal neurological function
Baclofen Kinetics • GABA derivative • Onset of effect in 30-40 mins • Peak levels in 2hrs • Route of excretion : Renal 70-90% • Half life 3-4h,
Baclofen levels (microg/L) • 7/2/8 (D2) pm 610 • 8/2/8 1045 320 • 1645 208 • 2300 140 • Therapeutic range = 80-400microg/l • Ventilated despite levels • Half-life = 10hrs
Paediatric overdose • Baclofen party! • 14 symptomatic, 9 intubated • Of 8 pts - coma (7), hypothermia (6) bradycardia (5) arrythmias (PVC) (3), convulsions (2) • Persistent symptoms despite levels • All discharged within 5 days
Baclofen toxicity • Multiple adult reports in literature- • Prolonged recovery phase noted • Elimination rate from nerve tissue much slower • Toxicity unmasking renal failure
Root Cause Analysis (Compiled by Dr McIntosh, PICU)
Root Cause Analysis: Good Points • Frequent reviews • Appropriate management plan • Senior review
Problems • Baclofen dose is wrong • Delay in escalation of care • Initial differential of sepsis/dehydration not in keeping with bradycardia.
RCA: Baclofen dose too high • Why? • Because that is the maintenance BNF dose for age for children with normal renal function • Why not give the renal failure dose? • Not identified as needing to • Why not? • Renal function (estimated GFR) was given on flow sheet & in previous letters • Not in latest electronic letter
Baclofen dose too high • Urology team may not look at flow sheets • May not look for GFR • No suggestion that the BNF dose for renal impairment was misread • No suggestion that GFR was looked at and thought satisfactory
Root Cause • Failure to identify patient in renal failure who needs dose adjusting
Suggestions • CRF patients sticker on • notes • drug charts • eGFR in letters • Induction • On-going education
Suggestions • 5. Poster at nurses station • 6. BNFC is vague in the renal dose alteration. Communication has been made with them. • 7. Audit
References Holly E. Perry , Robert O. Wright , Michael W. Shannon , and Alan D. Woolf Baclofen Overdose: Drug Experimentation in a Group of AdolescentsPediatrics, Jun 1998; 101: 1045 - 1048. D. J. Lipscomb and T. J. MeredithBaclofen overdose.Postgrad. Med. J., Feb 1980; 56: 108 - 109.
Acknowledgments • Tamsin Griffiths Spr • Mark Tomlin- Consultant pharmacist SUHT • Shuman Haq – Consultant Paediatric Nephroloist