title: Phenobarbital versus morphine in the management of neonatal abstinence syndrome, a randomized control trial.
abstract: BACKGROUND
  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.
  
  
  BACKGROUND
  This study is registered at the Iranian Registry of Clinical Trials ( www.irct.ir ) which is a Primary Registry in the WHO Registry Network. (Registration Number =  IRCT201406239568N8 ).
authors.affiliation: Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran. fnayeri@sina.tums.ac.ir.|Breastfeeding Research Center, Tehran University of Medical Sciences, Tehran, Iran. fnayeri@sina.tums.ac.ir.
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Nayeri
authors.affiliation: Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran. mahdisheikh@gmail.com.|Breastfeeding Research Center, Tehran University of Medical Sciences, Tehran, Iran. mahdisheikh@gmail.com.
authors.forename: Mahdi
authors.initials: M
authors.lastname: Sheikh
authors.affiliation: Department of Neonatology, Akbar-Abadi Hospital, Iran University of Medical Sciences, Tehran, Iran. mahduni@icloud.com.
authors.forename: Majid
authors.initials: M
authors.lastname: Kalani
authors.affiliation: Pediatrics Department, Kerman University of Medical Sciences, Kerman, Iran. Pniknaffs@yahoo.com.
authors.forename: Pedram
authors.initials: P
authors.lastname: Niknafs
authors.affiliation: Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran. mshariat@tums.ac.ir.|Breastfeeding Research Center, Tehran University of Medical Sciences, Tehran, Iran. mshariat@tums.ac.ir.
authors.forename: Mamak
authors.initials: M
authors.lastname: Shariat
authors.affiliation: Breastfeeding Research Center, Tehran University of Medical Sciences, Tehran, Iran. hoseindalili@yahoo.com.
authors.forename: Hosein
authors.initials: H
authors.lastname: Dalili
authors.affiliation: Department of Pharmacology, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran. dehpour@medscape.com.
authors.forename: Ahmad-Reza
authors.initials: AR
authors.lastname: Dehpour
mesh_terms: D000284:Administration, Oral; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D004334:Drug Administration Schedule; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D007231:Infant, Newborn; D007492:Iran; D007902:Length of Stay; D009020:Morphine / Q000627:therapeutic use*; D009357:Neonatal Abstinence Syndrome / Q000188:drug therapy*; D010634:Phenobarbital / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D006993:Hypnotics and Sedatives; D009020:Morphine; D010634:Phenobarbital