Comparative Efficacy of Oral Triclofos in Pediatric Neuroimaging and Other Procedural Sedation: A Systematic Review and Meta-analysis

Procedural sedation is mandatory for various diagnostic and therapeutic procedures in uncooperative or struggling children. many drugs are advocated, but there is no consensus on drug choice, route of administration, and dose to be given. practice varies by country, area, procedure, and clinician widely. the oral way is always preferred for its accessible acceptability, lower cost, and broader safety margin. oral medication does not require expert handling by anesthetists, whose availability is usually complicated. triclofos is the active metabolite of chloral hydrate. it is used as an oral sedative and anxiolytic. chloral hydrate and triclofos lost their ground when they suffered a ban in the year 2000 in the united states of america. they received another setback when they were included in the world health organization (who) list of restricted pharmaceuticals in 2010. although unmonitored drug misuse, causing severe side effects, and even death were the reasons behind the ban, different countries also stopped its monitored and supervised use. however, triclofos remained in use in india, and no severe side effects were noted in its one-time use under medical supervision for procedural sedation in the last 20 years. therefore, this systematic review and meta-analysis were undertaken to ascertain its safety and efficacy. the protocol was registered at prospero vide no crd42021237574. twenty-four studies with 2337 subjects were included, comprising 18 clinical trials for safety and efficacy, while six observational studies were included for safety only. triclofos and oral midazolam appeared as preferred drugs for procedural sedation without any statistically significant difference in effectiveness and safety. triclofos was used in much higher doses in all studies, varying from 2.5 to 5 times higher than the recommended dose of 20 mg/kg in indian books. preservative-free intravenous midazolam preparation mixed with fruit juice was commonly used orally. no severe side effects were noted for triclofos in any study. it was concluded that one-time use of triclofos under medical supervision is safe and effective.