Clonidine effective in treating newborn opioid withdrawal syndrome: AAP

A new study published in the journal of Pediatrics showed that there was no significant difference in the duration of pharmacologic therapy or the final neurobehavioral performance between the groups treated with morphine and clonidine. Overdose deaths, maternal deaths, and newborn abstinence syndrome (NAS), which has both immediate and long-term effects, have all increased as a result of the opioid pandemic in the US. Misuse of opioids or their prescription usage for chronic pain management or treatment for opioid use disorder (MOUD) can expose a fetus.

The observed deleterious consequences of in utero opioid exposure on the developing brain include neonatal stroke, hydrocephaly, decreased brain cell number, small head size, postnatal head development retardation, lower brain sizes, and related long-term cognitive deficiencies and behavioral disorders. To ascertain if clonidine which is a non-opioid α−2-adrenergic agonist would be an effective treatment for newborn opioid withdrawal syndrome (NOWS), Henrietta Bada and her colleagues carried out this investigation.

Prenatal opioid exposure, gestational age ≥35 weeks, absence of any other medical conditions, and need for medication were among the requirements for enrolment in this randomized clinical study. Neurobehavioral performance and treatment duration were the main outcomes measured.

In all, 1107 patients underwent enrolment screening (645 were deemed ineligible, 91 parents or staff were unavailable, 216 rejected, and 155 gave their approval). Out of the 155 neonates, 120 needed therapy and were randomly assigned to receive either 0.06 mg/kg/dose of morphine or 1 µg/kg/dose of oral clonidine every three hours.

Every 12 to 24 hours, the dosages for infants who showed no improvement were raised by 25%. Adjunctive treatment was administered to the ones who did not improve by the fourth dosage increment. With median treatment durations of 15 and 17, respectively, morphine and clonidine did not differ in length.

More babies treated with clonidine required adjunct treatment (adjusted odds ratio = 8.85) when compared to 10% in the morphine group. Following therapy, there was no difference in the NICU Network Neurobehavioral Scales summary scores between babies treated with clonidine and the babies treated with morphine.

Overall, the duration of pharmacologic therapy and the ultimate evaluation of neurobehavioral function did not differ substantially between the groups treated with clonidine and morphine in a randomized experiment. To increase effectiveness and reduce the need for supplementary treatment in NOWS, more research and dedicated studies are required to determine the ideal dosage and frequency of clonidine administration.

Reference:

Bada, H. S., Westgate, P. M., Sithisarn, T., Yolton, K., Charnigo, R., Pourcyrous, M., Tang, F., Gibson, J., Shearer-Miller, J., Giannone, P., & Leggas, M. (2024). Clonidine as Monotherapy for Neonatal Opioid Withdrawal Syndrome: A Randomized Trial. In Pediatrics. American Academy of Pediatrics (AAP). https://doi.org/10.1542/peds.2023-065610