Opioid use and naloxone-identified suspected opioid-related adverse events in a tertiary pediatric hospital: a retrospective study

OBJECTIVE: Opioids are essential for analgesia and sedation in pediatric inpatient care, particularly in perioperative and intensive care settings. However, their use requires careful monitoring because children, especially infants and critically ill patients, may be vulnerable to respiratory, cardiovascular, and neurological adverse effects. METHODS: This retrospective observational study evaluated opioid administration records and naloxone-identified suspected opioid-related adverse-event episodes at a tertiary pediatric hospital in Brazil from January 2019 to September 2024. Opioid administration records were identified from hospital pharmacy dispensing data. Medical records of patients with naloxone administration records were reviewed to classify naloxone indication, opioid involvement, clinical manifestations, hospital setting, underlying conditions, and short-term outcomes. RESULTS: During the study period, 154,867 opioid administration records were identified. A total of 284 naloxone administration records were screened. After medical record review, 171 naloxone administrations did not meet criteria for suspected opioid-related adverse-event episodes and were excluded from the main adverse-event analysis. The final naloxone-identified sample included 112 episodes. Events occurred predominantly in intensive care settings, especially the cardiac intensive care unit. The most frequently documented manifestations were bradycardia, oxygen desaturation, apnea, chest wall rigidity, drowsiness/somnolence, and worsened respiratory pattern. Most episodes improved after naloxone administration. CONCLUSION: Naloxone-identified suspected opioid-related adverse-event episodes were uncommon relative to the total volume of opioid administration records and were concentrated in clinically complex pediatric inpatients. These findings support risk-stratified monitoring, standardized documentation of naloxone indications, and continued opioid stewardship in tertiary pediatric care.