경구 Chloral Hydrate 시럽(Pocral® Syrup) 과연 안전한가?
Is Chloral Hydrate Syrup(PocralⓇ Syrup) a Safe Oral Sedative?
0
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
Chloral hydrate synthesized by the chlorination of ethanol, has been used empirically since 1890s. Now, Pocral® syrup, the commercialized oral form, is the main stream of oral sedatives in Korean pediatric dentistry. However, the safety of chloral hydrate is not approved by FDA as it has been used before FDA started to review drugs. Over decades, severe complications related to the overuse of chloral hydrate have been occurred through out the world even in Korea. Interestingly, the pharmaceutical companies in the States stop their marketing since 2012 due to its safety issue and the releasing of FDA guideline for unapproved drugs in 2006. In America, there is an alternative of Pocral® syrup, or midazolam syrup, for pediatric oral sedation. However, there is no midazolam syrup in Korea. Basically, Pocral® syrup is known as a safe oral sedative when administered appropriately according to the manufacturer’s information. The major cause of severe complications of pediatric sedation is related to over- or mis-use of chloral hydrate syrup. Already, many Korean pediatric dentists are accustomed to using Pocral® syrup and they know its advantages and disadvantages. According to most guidelines of pediatric sedation, we can use Pocral® syrup up to 70 mg/kg.
Abstract
Chloral hydrate synthesized by the chlorination of ethanol, has been used empirically since 1890s. Now, Pocral® syrup, the commercialized oral form, is the main stream of oral sedatives in Korean pediatric dentistry. However, the safety of chloral hydrate is not approved by FDA as it has been used before FDA started to review drugs. Over decades, severe complications related to the overuse of chloral hydrate have been occurred through out the world even in Korea. Interestingly, the pharmaceutical companies in the States stop their marketing since 2012 due to its safety issue and the releasing of FDA guideline for unapproved drugs in 2006. In America, there is an alternative of Pocral® syrup, or midazolam syrup, for pediatric oral sedation. However, there is no midazolam syrup in Korea. Basically, Pocral® syrup is known as a safe oral sedative when administered appropriately according to the manufacturer’s information. The major cause of severe complications of pediatric sedation is related to over- or mis-use of chloral hydrate syrup. Already, many Korean pediatric dentists are accustomed to using Pocral® syrup and they know its advantages and disadvantages. According to most guidelines of pediatric sedation, we can use Pocral® syrup up to 70 mg/kg.
참고문헌 (19)
- American Academy of Pediatrics Committee on Drugs and Committee on Environmental Health, "Use of chloral hydrate for sedation in children", Pediatrics, 92, pp.471~473 (1993)
- Pershad J, "Chloral hydrate : the good and the bad", Pediatr Emerg Care, 15, pp.432~435 (1999)
- Meadows M, "The FDA takes action against unapproved drugs", FDA Consumer magazine, ~ (2007)
- Cote CJ, "Sedation for the pediatric patient. A review", Pediatr Clin North Am, 41, pp.31~58 (1994)
- Hirsch IA, "Chloral hydrate : a potential cause of arrhythmias", Anesth Analges, 65, pp.691~692 (1986)
- Rokicki W, "Cardiac arrhythmia in a child after the usual dose of chloral hydrate", Pediatr Cardiol, 17, pp.419~420 (1996)
- Ghershanik JJ, "Monitoring levels of trichloroethanol during chloral hydrate administration to sick neonates", Clin Res, 29, pp.895~ (1981)
- Heller PF, "Chloral hydrate overdose : trichloroethanol detection by gas chromatography", mass spectrometry, 1992, pp.52(2), 231~234
- Abbas R, "A physiologically based pharmacokinetic model for trichloroethylene, and its metabolites, chloral hydrate, trichloroacetate, dichloroacetate, trichloroethanol, and trichloroethanol glucuronide in B6C3F1 mice", Toxicol Appl Pharmacol, 137, pp.15~30 (1997)
- Beland FA, "Metabolism of chloral hydrate in mice and rats after single and multiple doses", J Toxicol Environ Health, 54, pp.209~226 (1998)
- Vade A, "Chloral hydrate sedation of children undergoing CT and MR imaging : safety as judged by American Academy of Pediatrics Guidelines", AJR Am J Roentgenol, 165, pp.905~909 (1995)
- Yam KL, "Pilot Study in Evaluating the Side Effects of Chloral Hydrate Sedation in Children", HK J Paediatr, 7, pp.214~219 (2002)
- Greenberg SB, "High dose chloral hydrate sedation for children undergoing CT", J Comput Assist Tomogr, 15, pp.467~469 (1991)
- Marti-Bonmati L, "Randomised double-blind clinical trial of intermediate-versus high-dose chloral hydrate for neuroimaging of children", Neuroradiology, 37, pp.687~691 (1995)
- Dean RP, "Interaction of chloral hydrate and intravenous furosemide in a child", Clin Pharmacy, 10, pp.385~387 (1991)
- Steinberg AD, "Should chloral hydrate be banned?", Pediatrics, 92, pp.442~446 (1993)
- Smith MT, "Chloral hydrate warning", Science, 250, pp.359~ (1990)
- Leuschner J, "Studies on the mutagenic and carcinogenic potential of chloral hydrate", Arzneimittelforschung, 48, pp.961~968 (1998)
- Benson R, "Concise International Chemical Assessment Document 25", ~ (2000)