Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2010 Jun;164(6):554-60.
doi: 10.1001/archpediatrics.2010.75.

Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center

Ruwan Kiringoda  1 , Audrey E Thurm, Matthew E Hirschtritt, Deloris Koziol, Robert Wesley, Susan E Swedo, Naomi P O'Grady, Zenaide M N Quezado
Affiliations

Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center

Ruwan Kiringoda et al. Arch Pediatr Adolesc Med. 2010 Jun.

Abstract

Objectives: To quantify the incidence of adverse events associated with anesthesia given for research-driven imaging studies and to identify risk factors for those events in pediatric research subjects.

Design: Retrospective cohort study.

Setting: National Institutes of Health Clinical Center.

Participants: Children and adolescents enrolled in clinical research protocols who required anesthesia for research-related imaging studies from January 2000 to September 2008.

Intervention: Propofol sedation/anesthesia.

Main outcome measure: The occurrence of respiratory, cardiovascular, and all anesthesia-related adverse events that required intervention while receiving anesthetics for research-driven imaging studies and other noninvasive procedures.

Results: We identified 607 children who received 1480 propofol anesthetic procedures for imaging studies. Seventy percent of anesthetics were given to subjects with severe diseases and significant disabilities (American Society of Anesthesiologists Physical Status [ASA] III). Anesthesia had a mean (SD) duration of 115 (55) minutes, and in 12.5% of procedures, an airway device was necessary. There were 98 notable respiratory, cardiovascular, and other events in 79 anesthetic procedures, a rate of 534 per 10 000 anesthetic procedures with 1 or more adverse events. There was no long-lasting morbidity or mortality. The ASA classification (odds ratio [OR], 2.92; 95% confidence interval [CI], 1.24-6.88), anesthetic effect duration (OR, 1.46; 95% CI, 1.25-1.70), and presence of airway abnormalities (OR, 4.41; 95% CI, 1.60-12.12) were independently associated with adverse events during anesthetic use.

Conclusion: In our clinical research sample of high-risk children who received sedation/anesthesia by an anesthesiologist, we observed a low incidence of adverse events and no long-term complications. Risk factors for adverse events included higher ASA classification, increasing anesthetic duration, and presence of airway abnormalities.

PubMed Disclaimer

Comment in

References

    1. Department of Health and Human Services. Additional protection for children involved as subjects in research. 45 CFR §46.401-46.409.
    1. Field MJ, Behrman RE, editors. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press; 2004. - PubMed
    1. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA. 2004;291(4):476–482. - PubMed
    1. Wendler D, Belsky L, Thompson KM, Emanuel EJ. Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit. JAMA. 2005;294(7):826–832. - PubMed
    1. Cravero JP. Risk and safety of pediatric sedation/anesthesia for procedures outside the operating room. Curr Opin Anaesthesiol. 2009;22(4):509–513. - PubMed

Publication types