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Procedural Sedation Outside the Operating Room and Potential Neurotoxicity: Analysis of an At-Risk Pediatric
Pradip P Kamat1, Carmen Sulton2, Sapna R Kudchadkar3
1Children's Healthcare of Atlanta at Egleston, Ga (PP Kamat, C Sulton, CE McCracken, and HK Simon); Departments of Pediatrics, Division of Critical Care Medicine (PP Kamat),.
Insights
Young children frequently require repeated or prolonged procedural sedation (PS) for procedures like MRI, raising concerns about potential neurotoxicity. Awareness of FDA warnings is crucial for managing risks in this vulnerable population.
Area of Science:
- Pediatric Anesthesiology
- Neuroscience
- Radiology
Background:
- The US Food and Drug Administration (FDA) issued a warning in 2016 regarding potential neurotoxicity associated with procedural sedation (PS) in young children.
- Infants and children under 3 years old are considered a vulnerable population for neurodevelopmental effects.
- Understanding the characteristics of children receiving PS is crucial for risk assessment and management.
Purpose of the Study:
- To identify the characteristics of children who met the risk criteria for potential neurotoxicity as defined by the FDA warning.
- To analyze the demographics, duration, and reasons for procedural sedation in children under 3 years old.
- To assess the incidence of repeated and prolonged sedation in this population.
Main Methods:
- A single-center retrospective review was conducted.
- Data from infants and children aged <3 years receiving procedural sedation outside the operating room between 2014 and 2016 were analyzed.
- Demographic information, duration of sedation, and reasons for sedation were examined.
Main Results:
- A total of 2950 patients with 3653 sedation encounters were included.
- The median age was 19 months, with 86.4% of sedations for magnetic resonance imaging (MRI).
- 11.1% of patients required repeated and/or prolonged sedation (>3 hours), most commonly for brain MRI and neurologic concerns.
Conclusions:
- Multiple and prolonged procedural sedation is common in young children outside the operating room.
- While some imaging is unavoidable, alternative strategies like delaying procedures or using different imaging techniques should be considered.
- Increased awareness among families and providers regarding FDA warnings on sedation neurotoxicity is essential.
Objectives:
To determine the characteristics of children who met the risk criteria for potential neurotoxicity defined by the US Food and Drug Administration (FDA; 2016 warning) in a procedural sedation (PS) service.
Study Design:
A single-center retrospective review of all infants and children aged <3 years receiving PS outside the operating room from 2014 to 2016. Demographics, duration of, and the reason for PS were analyzed.
Results:
A total of 2950 patients with 3653 sedation encounters were included. Median age was 19 (range, 11-26) months. Most PS (86.4%) were for magnetic resonance imaging (MRI). The median number of sedation procedures per patient was 1 (25th-75th: 1-7), and median duration of sedation was 72 minutes (25th-75th: 55-98 minutes). Forty patients (1.4%) required prolonged sedations >3 hours, in a single encounter (median, [25th-75th] of 196 minutes [185-214 minutes]), and 298 patients (10.1%) had multiple sedation exposures during the study period. Overall, 327 patients, 11.1% (95% confidence interval, 10.0%-12.3%) required repeated and/or prolonged sedation. The most common reasons for repeated or prolonged sedation were MRI of the brain and neurologic concerns.
Conclusions:
Multiple and prolonged PS commonly occurs outside the operating room in this young and potentially vulnerable population. Although certain imaging cannot be avoided, other cases may have the potential to be delayed until the child is >3 years old or to have alternate imaging that may not require prolonged PS. Family and provider awareness of the FDA warnings regarding potential neurotoxicity of sedation in all settings, both inside and outside the operating room, is critical.
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