Bhatt M, et al. - This study was formulated in order to inspect the incidence and risk factors connected with sedation-related serious adverse events (SAEs). A substantial variation was discovered in the incidence of adverse sedation outcomes with the type of sedation medication. A link was reported between the use of ketamine only with the best outcomes. This result led to considerably fewer SAEs and interventions than ketamine combined with propofol or fentanyl.

Methods

• The scheme of this trial was a prospective, multicenter, observational cohort study.
• It was performed in 6 pediatric emergency departments in Canada between July 10, 2010, and February 28, 2015.
• The recruitment consisted of children 18 years or younger who received sedation for a painful emergency department procedure.
• Amongst the 9,657 patients eligible for inclusion, 6,760 (70.0%) were eligible and 6,295 (65.1%) were included in the final analysis.
• The primary risk factor was determined as the receipt of sedation medication.
• Demographic characteristics, preprocedural medications and fasting status, current or underlying health risks, and procedure type served as the secondary risk factors.
• The primary outcome included the analysis of 4 outcomes: SAEs, significant interventions performed in response to an adverse event, oxygen desaturation, and vomiting.

Results

• Among those included in the final analysis, 4190 (66.6%) were male and the mean (SD) age was 8.0 (4.6) years.
• The occurrence of adverse events was reported in 736 patients (11.7%; 95% CI, 6.4%-16.9%).
• Oxygen desaturation (353 patients [5.6%]) and vomiting (328 [5.2%]) were discovered to be the most common of these adverse events.
• A significant intervention was found in 69 SAEs (1.1%; 95% CI, 0.5%-1.7%), and 86 patients (1.4%; 95% CI, 0.7%-2.1%).
• The sole use of ketamine hydrochloride was responsible for the lowest incidence of SAEs (17 [0.4%]) and significant interventions (37 [0.9%]).
• Marked variation was reported in the incidence of adverse sedation outcomes with the type of sedation medication.
• Propofol alone (3.7%; odds ratio [OR], 5.6; 95% CI, 2.3-13.1) and the combinations of ketamine and fentanyl citrate (3.2%; OR, 6.5; 95% CI, 2.5-15.2) and ketamine and propofol (2.1%; OR, 4.4; 95% CI, 2.3-8.7) illustrated the highest incidence of SAEs, compared with ketamine alone.
• The combinations of ketamine and fentanyl (4.1%; OR, 4.0; 95% CI, 1.8-8.1) and ketamine and propofol (2.5%; OR, 2.2; 95% CI, 1.2-3.8) exhibited the highest incidence of significant interventions.