Objective: The objective of this study was to determine the safety profile of propofol as a deep-sedation agent in a primarily outpatient program consisting of pediatric critical care physicians and specifically trained nurses with oversight provided by anesthesiology. One hypothesis was investigated: adverse events and/or airway interventions are more likely to occur in children with an abnormal airway score.
Methods: A 36-month dual-site prospective, observational, clinical study was conducted in a single center with interchangeable providers operating within the guidelines of a single sedation program. A total of 7304 propofol sedations for 4464 unique patients who ranged in age from 1 month to 21 years were studied; >97% of the children were >1 year of age.
Results: The following adverse reactions were identified, and a descriptive statistical analysis of the data were performed: mild oxygen desaturation (85%-90%), 1.73%; serious oxygen desaturation (<85%), 2.9%; laryngospasm, 0.27%; regurgitation without aspiration, 0.05%; regurgitation with aspiration, 0.01%; bronchospasm, 0.15%; and hypotension, 31.4%. Interventions required included oral airway, 0.96%; nasal trumpet, 1.57%; rescue breaths for >1 minute, 0.37%; intubation, 0.03%; volume requirement of >40 mL/kg per hour, 0.11%; sedation-induced ward or PICU admission, 0.04%; cardiac arrest medications, 0%; and aborted sedation or procedure, 0%. We devised an airway score to identify at-risk patients. Patients with an abnormal airway score were significantly more likely to: have oxygen desaturation (13.1% vs 4.3%); require an oral airway (5.9% vs 0.8%); and require a nasal trumpet (13.9% vs 1.2%).
Conclusions: Propofol has an acceptable safety profile for deep sedation when used in the context of a program with critical care physicians, specifically trained nurses, and anesthesiology oversight. A preprocedure airway score can assist in identifying patients who may require airway interventions.