BMC Pediatrics | |
Phenobarbital versus morphine in the management of neonatal abstinence syndrome, a randomized control trial | |
Ahmad-Reza Dehpour2  Hosein Dalili4  Mamak Shariat4  Pedram Niknafs1  Majid Kalani3  Mahdi Sheikh4  Fatemeh Nayeri4  | |
[1] Pediatrics Department, Kerman University of Medical Sciences, Kerman, Iran;Department of Pharmacology, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran;Department of Neonatology, Akbar-Abadi Hospital, Iran University of Medical Sciences, Tehran, Iran;Breastfeeding Research Center, Tehran University of Medical Sciences, Tehran, Iran | |
关键词: Withdrawal; Pregnancy; Opioid; Dependency; Addicted; | |
Others : 1203841 DOI : 10.1186/s12887-015-0377-9 |
|
received in 2014-08-05, accepted in 2015-05-08, 发布年份 2015 | |
【 摘 要 】
Backgrounds
Evaluating the efficacy of the loading and tapering dose of Phenobarbital versus oral Morphine in the management of NAS.
Methods
This randomized, open-label, controlled trial was conducted on 60 neonates born to illicit drugs dependent mothers at Vali-Asr and Akbar-Abadi hospitals, Tehran, Iran, who exhibited NAS requiring medical therapy. The neonates were randomized to receive either: Oral Morphine Sulfate or a loading dose of Phenobarbital followed by a tapering dose. The duration of treatment required for NAS resolution, the total hospital stay and the requirement for additional second line treatment were compared between the treatment groups.
Results
The Mean ± Standard Deviation for the duration of treatment required for the resolution of NAS was 8.5 ± 5 days in the Morphine group and 8.5 ± 4 days in the Phenobarbital group (P = 0.9). The duration of total hospital stay was 12.6 ± 5.6 days in the Morphine group and 12.5 ± 5.3 days in the Phenobarbital group (P = 0.7). 3.3 % in the Morphine group versus 6.6 % in the Phenobarbital group required adjunctive treatment (P = 0.5).
Conclusions
There were no significant differences in the duration of treatment, duration of hospital stay, and the requirement for adjunctive treatment, between the neonates with NAS who received Morphine Sulfate and neonates who received a loading and tapering dose of Phenobarbital.
Trial registration
This study is registered at the Iranian Registry of Clinical Trials (www.irct.ir webcite) which is a Primary Registry in the WHO Registry Network. (Registration Number = IRCT201406239568N8 webcite)
【 授权许可】
2015 Nayeri et al.; licensee BioMed Central.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20150523020220327.pdf | 595KB | download | |
Fig. 2. | 18KB | Image | download |
Fig. 1. | 40KB | Image | download |
【 图 表 】
Fig. 1.
Fig. 2.
【 参考文献 】
- [1]Finnegan LP, Connaughton JF, Kron RE, Emich JP. Neonatal abstinence syndrome: assessment and management. Addict Dis. 1975; 2:141-58.
- [2]Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000–2009. JAMA. 2012; 307:1934-40.
- [3]Grim K, Harrison TE, Wilder RT. Management of neonatal abstinence syndrome from opioids. Clin Perinatol. 2013; 40:509-24.
- [4]Kocherlakota P. Neonatal abstinence syndrome. Pediatrics. 2014; 134:e547-61.
- [5]Hudak ML, Tan RC. Neonatal drug withdrawal. Pediatrics. 2012; 129:e540-60.
- [6]Fulroth R, Phillips B, Durand DJ. Perinatal outcome of infants exposed to cocaine and/or heroin in utero. Am J Dis Child. 1989; 143:905-10.
- [7]Smith L, Yonekura ML, Wallace T, Berman N, Kuo J, Berkowitz C. Effects of prenatal methamphetamine exposure on fetal growth and drug withdrawal symptoms in infants born at term. J Dev Behav Pediatr. 2003; 24:17-23.
- [8]Rockville, MD. Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13–4795.
- [9]Napolitano A, Theophilopoulos D, Seng SK, Calhoun DA. Pharmacologic management of neonatal abstinence syndrome in a community hospital. Clin Obstet Gynecol. 2013; 56:193-201.
- [10]Finnegan LP, Kaltenbach K. Neonatal abstinence syndrome. In: Hoekelman RA, Friedman SB, Nelson NM, Weitzman ML, Wilson MH editors. Primary pediatric care. 2nd ed. Mosby, St. Louis; 1992 p. 1367–78.
- [11]Kraft WK, Dysart K, Greenspan JS, Gibson E, Kaltenbach K, Ehrlich ME. Revised dose schema of sublingual buprenorphine in the treatment of the neonatal opioid abstinence syndrome. Addiction. 2011; 106:574-80.
- [12]Liu A, Bjorkman T, Stewart C, Nanan R. Pharmacological treatment of neonatal opiate withdrawal: between the devil and the deep blue Sea. Int J Pediatrics. 2011;2011.
- [13]Kraft WK, van den Anker JN. Pharmacologic management of the opioid neonatal abstinence syndrome. Pediatr Clin N Am. 2012; 59:1147-65.
- [14]Jackson L, Ting A, McKay S, Galea P, Skeoch C. A randomised controlled trial of morphine versus phenobarbitone for neonatal abstinence syndrome. Arch Dis Child Fetal Neonatal Ed. 2004; 89:F300-4.
- [15]Ebner N, Rohrmeister K, Winklbaur B, Baewert A, Jagsch R, Peternell A et al.. Management of neonatal abstinence syndrome in neonates born to opioid maintained women. Drug Alcohol Depend. 2007; 87:131-8.
- [16]Choquet M, Morin D, Hassler C, Ledoux S. Is alcohol, tobacco, and cannabis use as well as polydrug use increasing in France? Addict Behav. 2004; 29:607-14.
- [17]Finnegan LP, Mitros TF, Hopkins LE. Management of neonatal narcotic abstinence utilizing a phenobarbital loading dose method. NIDA Res Monogr. 1979; 27:247-53.
- [18]O’Grady MJ, Hopewell J, White MJ. Management of neonatal abstinence syndrome: a national survey and review of practice. Arch Dis Child Fetal Neonatal Ed. 2009; 94:F249-52.
- [19]Osborn DA, Jeffery HE, Cole MJ. Sedatives for opiate withdrawal in newborn infants. Cochrane Database Syst Rev. 2010:CD002053
- [20]Finnegan LP, Michael H, Leifer B, Desai S. An evaluation of neonatal abstinence treatment modalities. NIDA Res Monogr. 1984; 49:282-8.
- [21]Kahn EJ, Neumann LL, Polk GA. The course of the heroin withdrawal syndrome in newborn infants treated with phenobarbital or chlorpromazine. J Pediatr. 1969; 75:495-500.