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

Abstract

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 ) which is a Primary Registry in the WHO Registry Network. (Registration Number =  IRCT201406239568N8 ).

• Authors: Fatemeh Nayeri, Mahdi Sheikh, Majid Kalani, Pedram Niknafs, Mamak Shariat, Hosein Dalili, Ahmad-Reza Dehpour
• Journal: BMC pediatrics (BMC Pediatr) Vol. 15 Pg. 57 (May 15 2015) ISSN: 1471-2431 [Electronic] England
• PMID: 25976238 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics, Opioid
• Hypnotics and Sedatives
• Morphine
• Phenobarbital

Topics

• Administration, Oral
• Analgesics, Opioid (therapeutic use)
• Chemotherapy, Adjuvant
• Drug Administration Schedule
• Humans
• Hypnotics and Sedatives (therapeutic use)
• Infant, Newborn
• Iran
• Length of Stay
• Morphine (therapeutic use)
• Neonatal Abstinence Syndrome (drug therapy)
• Phenobarbital (therapeutic use)
• Prospective Studies
• Treatment Outcome