Clonidine versus phenobarbital as adjunctive therapy for neonatal abstinence syndrome.

OBJECTIVE

To compare clonidine versus phenobarbital as adjunctive therapy in infants who failed monotherapy with morphine for neonatal abstinence syndrome (NAS).

STUDY

DESIGN

Prospective, randomized, open-label study of infants ≥ 35 weeks' gestation. Infants received clonidine or phenobarbital per protocol. Primary outcome was morphine treatment days. Secondary outcomes were inpatient adjunctive days, length of stay (LOS), triple therapy, safety, and readmission rates.

RESULTS

A total of 25 infants were treated with clonidine (n = 14) or phenobarbital (n = 11). Mean morphine treatment duration was significantly longer with clonidine (34.4 days, SD = 10.6) compared with phenobarbital (25.5 days, SD = 7.3, p = 0.026). The clonidine group also had higher inpatient adjunctive days (mean: 33.8 days [SD = 14.3] vs. 22 days [SD = 12.6], p = 0.042) and LOS (mean: 41.8 days [SD = 10.9] vs. 31 days [SD = 10]; p = 0.018) compared with phenobarbital.

CONCLUSIONS

Phenobarbital, as adjunctive therapy, led to significantly shorter duration of morphine therapy, inpatient adjunctive days, and length of stay compared with clonidine.