OBJECTIVE: The purpose of this study was to test the hypothesis that treatment of neonatal opiate withdrawal (NOW) in the term infant with diluted tincture of opium (DTO) and phenobarbital was superior to treatment with DTO alone. STUDY DESIGN: This was a partially randomized, controlled trial in which 20 term infants exposed tomethadone and/or heroin in utero were studied. The severity of NOW was assessed by using the Finnegan scoring system. Infants were assigned to either DTO and placebo (n = 10) or DTO and phenobarbital (n = 10) when medication was required. The primary outcome variable was the duration of hospitalization. Severity of withdrawal and hospital cost were secondary outcome variables. RESULTS: There were no significant differences in the gestational age, growth variables, maternal methadone dose, or age at enrollment between the 2 groups. The duration of hospitalization was reduced by 48% (79-38 days) (P <.001) and hospital cost per patient reduced by $35,856 (P <.001) for the DTO and phenobarbital group. Furthermore, these infants spent less time with severe withdrawal (P <.04), more time with mild withdrawal (P <.03), and required a lower maximum daily DTO dose (P <.009) when compared with the DTO-only group. The average duration of outpatient phenobarbital use was 3.5 months. CONCLUSIONS: The combined use of DTO and phenobarbital resulted in a shorter duration of hospitalization, less severe withdrawal, and reduced hospital cost. This combination may be a preferred regimen for the treatment of NOW.
RCT Entities:
OBJECTIVE: The purpose of this study was to test the hypothesis that treatment of neonatal opiate withdrawal (NOW) in the term infant with diluted tincture of opium (DTO) and phenobarbital was superior to treatment with DTO alone. STUDY DESIGN: This was a partially randomized, controlled trial in which 20 term infants exposed to methadone and/or heroin in utero were studied. The severity of NOW was assessed by using the Finnegan scoring system. Infants were assigned to either DTO and placebo (n = 10) or DTO and phenobarbital (n = 10) when medication was required. The primary outcome variable was the duration of hospitalization. Severity of withdrawal and hospital cost were secondary outcome variables. RESULTS: There were no significant differences in the gestational age, growth variables, maternal methadone dose, or age at enrollment between the 2 groups. The duration of hospitalization was reduced by 48% (79-38 days) (P <.001) and hospital cost per patient reduced by $35,856 (P <.001) for the DTO and phenobarbital group. Furthermore, these infants spent less time with severe withdrawal (P <.04), more time with mild withdrawal (P <.03), and required a lower maximum daily DTO dose (P <.009) when compared with the DTO-only group. The average duration of outpatientphenobarbital use was 3.5 months. CONCLUSIONS: The combined use of DTO and phenobarbital resulted in a shorter duration of hospitalization, less severe withdrawal, and reduced hospital cost. This combination may be a preferred regimen for the treatment of NOW.
Authors: Walter K Kraft; Kevin Dysart; Jay S Greenspan; Eric Gibson; Karol Kaltenbach; Michelle E Ehrlich Journal: Addiction Date: 2010-10-06 Impact factor: 6.526
Authors: Andrew A Somogyi; Mie Larsen; Reza M Abadi; Jaroon Jittiwutikarn; Robert Ali; Jason M White Journal: Br J Clin Pharmacol Date: 2008-11 Impact factor: 4.335
Authors: Irma Convertino; Alice Capogrosso Sansone; Alessandra Marino; Maria T Galiulo; Stefania Mantarro; Luca Antonioli; Matteo Fornai; Corrado Blandizzi; Marco Tuccori Journal: Drug Saf Date: 2016-10 Impact factor: 5.606
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 Date: 2008-08-11 Impact factor: 7.124