Abstract
Aim
Triclofos sodium (TFS) has been used for many years in children as a sedative for painless medical procedures. It is physiologically and pharmacologically similar to chloral hydrate, which has been censured for use in children with neurocognitive disorders. The aim of this study was to investigate the safety and efficacy of TFS sedation in a pediatric population with a high rate of neurocognitive disability.
Methods
The database of the neurodiagnostic institute of a tertiary academic pediatric medical center was retrospectively reviewed for all children who underwent sedation with TFS in 2014. Data were collected on demographics, comorbidities, neurologic symptoms, sedation-related variables, and outcome.
Results
The study population consisted of 869 children (58.2% male) of median age 25 months (range 5–200 months); 364 (41.2%) had neurocognitive diagnoses, mainly seizures/epilepsy, hypotonia, or developmental delay. TFS was used for routine electroencephalography in 486 (53.8%) patients and audiometry in 401 (46.2%). Mean (± SD) dose of TFS was 50.2 ± 4.9 mg/kg. Median time to sedation was 45 min (range 5–245), and median duration of sedation was 35 min (range 5–190). Adequate sedation depth was achieved in 769 cases (88.5%). Rates of sedation-related adverse events were low: apnea, 0; desaturation ≤ 90%, 0.2% (two patients); and emesis, 0.35% (three patients). None of the children had hemodynamic instability or signs of poor perfusion. There was no association between desaturations and the presence of hypotonia or developmental delay.
Conclusion
TFS, when administered in a controlled and monitored environment, may be safe for use in children, including those with underlying neurocognitive disorders.
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Acknowledgements
We thank Mrs Pnina Lilos for her insights regarding the study design and assistance in the data analysis and interpretation.
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All authors including EK, AD, AW, DK, GK, RM, and EN have no conflicts of interest to disclose.
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No funding was secured for this study.
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The study was approved by the Institutional Review Board of Schneider Children’s Medical Center of Israel with a waiver of parental consent owing to the retrospective study design (RMC-0010-15).
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Kaplan, E., Daka, A., Weissbach, A. et al. Triclofos Sodium for Pediatric Sedation in Non-Painful Neurodiagnostic Studies. Pediatr Drugs 21, 371–378 (2019). https://doi.org/10.1007/s40272-019-00346-6
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DOI: https://doi.org/10.1007/s40272-019-00346-6