PURPOSE: Opioids have a narrow therapeutic index and have the potential to cause significant harm. Developmental and pharmacogenetic factors put children, and especially infants, at increased risk of complications. We performed a retrospective root cause analysis to identify the factors associated with critical incidents in children receiving opioid infusions in a tertiary care children's hospital. METHODS: Following institutional ethical approval, we identified potential critical incidents during 2004 to 2009 from patient safety and pharmacy data. Patients' medical charts were reviewed and a timeline of events that occurred before, during, and following each incident was generated. A safety assessment code score was assigned to each incident according to its severity and probability of recurrence, and incidents with a score ≥ 8 were selected for root cause analysis. Root causes were identified and classified, formal causal statements were written, and action plans were recommended. RESULTS: One hundred and sixty-six medical charts were reviewed, and 58 of these included one (45/58) or more (13/58) relevant critical incidents. The resulting harms were of minor to moderate severity. Fourteen incidents were submitted for detailed analysis, from which 31 root causes were identified. The most frequent and significant root causes involved defects in pre-printed order sheets, lack of a nursing guidelines for infusions (rate, adjustment, weaning), and inadequate guidelines for monitoring and recording pain, vital signs, and arousal scores. DISCUSSION: The root causes of a range of critical incidents have been identified, and these have been used to generate recommendations for improving both patient safety and quality of analgesia for children receiving opioid infusions for acute pain management.
PURPOSE: Opioids have a narrow therapeutic index and have the potential to cause significant harm. Developmental and pharmacogenetic factors put children, and especially infants, at increased risk of complications. We performed a retrospective root cause analysis to identify the factors associated with critical incidents in children receiving opioid infusions in a tertiary care children's hospital. METHODS: Following institutional ethical approval, we identified potential critical incidents during 2004 to 2009 from patient safety and pharmacy data. Patients' medical charts were reviewed and a timeline of events that occurred before, during, and following each incident was generated. A safety assessment code score was assigned to each incident according to its severity and probability of recurrence, and incidents with a score ≥ 8 were selected for root cause analysis. Root causes were identified and classified, formal causal statements were written, and action plans were recommended. RESULTS: One hundred and sixty-six medical charts were reviewed, and 58 of these included one (45/58) or more (13/58) relevant critical incidents. The resulting harms were of minor to moderate severity. Fourteen incidents were submitted for detailed analysis, from which 31 root causes were identified. The most frequent and significant root causes involved defects in pre-printed order sheets, lack of a nursing guidelines for infusions (rate, adjustment, weaning), and inadequate guidelines for monitoring and recording pain, vital signs, and arousal scores. DISCUSSION: The root causes of a range of critical incidents have been identified, and these have been used to generate recommendations for improving both patient safety and quality of analgesia for children receiving opioid infusions for acute pain management.