Phenobarbital versus morphine in the management of neonatal abstinence syndrome, a randomized control trial.

Fatemeh Nayeri,Ahmad-Reza Dehpour,Mahdi Sheikh,Pedram Niknafs,Mamak Shariat,Majid Kalani,Hosein Dalili

doi:10.1186/s12887-015-0377-9

Abstract

BackgroundsEvaluating the efficacy of the loading and tapering dose of Phenobarbital versus oral Morphine in the management of NAS.MethodsThis 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.ResultsThe 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).ConclusionsThere 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 registrationThis 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)

Highlights

Neonatal Abstinence Syndrome (NAS) is a set of signs and symptoms that can occur in the neonates due to intrauterine exposure to the opioids consumed by mothers
Descriptive statistics This study evaluated 60 neonates with NAS who had three consecutive Finnegan score of eight or more or two consecutive Finnegan score of 12 or more as calculated every 4 h by the physician. 30 neonates were randomly assigned to receive oral Morphine Sulfate and the other 30 were randomly assigned to receive Phenobarbital
No significant differences in the maternal consumed drugs were observed between the two treatment groups (Morphine versus Phenobarbital) (Table 3)

Summary

Introduction

Neonatal Abstinence Syndrome (NAS) is a set of signs and symptoms that can occur in the neonates due to intrauterine exposure to the opioids consumed by mothers. The syndrome mostly occurs in the context of antepartum opioid use, with the growing prevalence of illicit drug use, other drugs have been described to cause NAS [2,3,4,5,6,7]. The treatment rate is usually higher among poly substance and opioid exposed neonates (60–70 %) and lower in stimulants only exposed neonates (less than 10 %) whose the majority do not require pharmacologic treatment [4,5,6,7, 9]

Objectives

Methods

Results

Conclusion