Mark G. Roback

To compare the frequency and severity of adverse events associated with parenteral drugs commonly used for procedural sedation and analgesia (PSA) in a pediatric emergency department. A database of consecutive patients receiving parenteral PSA was prospectively generated with the intent of monitoring safety in the emergency department. Data were logged onto a dedicated sedation sheet. A retrospective analysis was performed; comparisons were made based on sedation drugs used. A total of 2,609 patients from June 1, 1996, to September 16, 2003, received PSA by emergency physicians. Patients who received PSA nonparenterally (n = 109) were excluded. A total of 2,500 patients (2,279, intravenous; 221, intramuscular) remained for analysis. Age range was 19 days to 32 years (median, 6.7 years). A total of 1,511 (60.4%) were male. Four major drug combinations were identified: ketamine alone (n = 1,492; 59.7%), ketamine/midazolam (n = 299; 12.0%), midazolam/fentanyl (n = 336; 13.4%), and midazolam alone (n = 260; 10.4%). A total of 113 patients (4.5%) received various other combinations of drugs. A total of 458 adverse events were observed in 426 patients (17%). Respiratory adverse events occurred as follows: ketamine alone, 91 patients (6.1%); ketamine/midazolam, 30 patients (10%); midazolam/fentanyl, 65 patients (19.3%); midazolam alone, 15 patients (5.8%). Vomiting occurred as follows: ketamine alone, 151 patients (10.1%); ketamine/midazolam, 16 patients (5.4%); midazolam/fentanyl, six patients (1.8%); midazolam alone, two patients (0.8%). Drug types used in pediatric PSA are associated with different adverse event profiles. Patients receiving ketamine with or without midazolam experienced fewer respiratory adverse events but more vomiting than the commonly used combination of midazolam and fentanyl. Adverse events may occur in any patient receiving parenteral PSA.