Abstract | OBJECTIVE: In utero exposure to drugs of abuse can lead to neonatal abstinence syndrome, a condition that is associated with prolonged hospitalization. Buprenorphine is a partial mu- opioid agonist used for treatment of adult detoxification and maintenance but has never been administered to neonates with opioid abstinence syndrome. The primary objective of this study was to demonstrate the feasibility and, to the extent possible in this size of study, the safety of sublingual buprenorphine in the treatment of neonatal abstinence syndrome. Secondary goals were to evaluate efficacy relative to standard therapy and to characterize buprenorphine pharmacokinetics when sublingually administered. METHODS: We conducted a randomized, open-label, active-control study of sublingual buprenorphine for the treatment of opiate withdrawal. Thirteen term infants were allocated to receive sublingual buprenorphine 13.2 to 39.0 mug/kg per day administered in 3 divided doses and 13 to receive standard-of-care oral neonatal opium solution. Dose decisions were made by using a modified Finnegan scoring system. RESULTS: CONCLUSIONS:
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Authors | Walter K Kraft, Eric Gibson, Kevin Dysart, Vidula S Damle, Jennifer L Larusso, Jay S Greenspan, David E Moody, Karol Kaltenbach, Michelle E Ehrlich |
Journal | Pediatrics
(Pediatrics)
Vol. 122
Issue 3
Pg. e601-7
(Sep 2008)
ISSN: 1098-4275 [Electronic] United States |
PMID | 18694901
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Narcotic Antagonists
- Buprenorphine
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Topics |
- Administration, Sublingual
- Buprenorphine
(administration & dosage, pharmacokinetics)
- Dose-Response Relationship, Drug
- Female
- Follow-Up Studies
- Gestational Age
- Humans
- Inactivation, Metabolic
- Infant, Newborn
- Male
- Narcotic Antagonists
(administration & dosage, pharmacokinetics)
- Neonatal Abstinence Syndrome
(blood, drug therapy)
- Retrospective Studies
- Treatment Outcome
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