IRCT201406239568N8 IRCT 2014-07-12 The Research Deputy of Tehran University of Medical Sciences Comparison of Phenobarbital versus Morphine in the management of neonatal abstinence syndrome Comparison of Phenobarbital versus Morphine in the management of neonatal abstinence syndrome, a randomized controlled trial 2009-08-15 anticipated 60 Complete https://irct.ir/trial/10133 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Neonatal Abstinence Syndrome. Intervention 1: Control Group: In the randomly assigned oral morphine treatment group, initially 1 ml of a 10 mg Morphine Sulfate vial was diluted using 24 ml of distilled water, to make final concentration of 0.4 mg/ml of Morphine, then depending on the Finnegan score drug is administered in 6 divided doses / 24 hours as follow: for a Finnegan score of 8-10: 0.24 mg/kg/24hours (0.6 ml/kg/24hours), for a Finnegan score of 11-13: 0.48 mg/kg/24hours (1.2 ml/kg/24hours), for a Finnegan score of 14-16: 0.64 mg/kg/24hours (1.6 ml/kg/24hours), and for a Finnegan score of 17 and above: 0.8 mg/kg/24hours (2 ml/kg/24hours) of Morphine Sulfate is administered. These doses of Morphine Sulfate continues until Finnegan score remains below 8 for 72 hours then the drug is weaned gradually by 10% of maximal dose every day until it is entirely discontinued at the cessation dose of 0.1 mg/kg/24hours of Morphine Sulfate. Intervention 2: Intervention Group: In the randomly assigned Phenobarbital treatment group, initially a loading dose of 20 mg/kg IV or IM is administered then if the symptoms persists another 5mg/kg is given every 8-12 hours until the entire loading dose would reach a maximum of 40 mg/kg. The maintenance dose is adjusted based on the loading dose and is initiated 12-24 hours after the last loading dose as follow: for a loading dose of 20 mg/kg the maintenance dose is 5 mg/kg/24 hours, for a loading dose of 30 mg/kg the maintenance dose is 6 mg/kg/24 hours, and for a loading dose of 40 mg/kg the maintenance dose is 8 mg/kg/24 hours administered IM or IV. These doses of Phenobarbital continued until Finnegan score remained below 8 for 72 hours then the drug is weaned gradually by 10% of maximal dose every day until it is entirely discontinued.