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Methadone effective in treating neonatal abstinence syndrome
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Methadone offers better short-term outcomes compared with morphine for treating infants with neonatal abstinence syndrome, according to recently published research in JAMA Pediatrics.
“As the number of pregnant women exposed to opioids and other psychotropic medications has increased, so has the incidence of neonatal abstinence syndrome (NAS),” Jonathan M. Davis, MD, vice-chair of pediatrics and chief of newborn medicine at the Floating Hospital for Children at Tufts Medical Center and professor of pediatrics at Tufts University School of Medicine, and colleagues wrote. “Although several different approaches are used to treat NAS, no universal standard exists. The use of opioids had been recommended for treatment of infants with significant NAS, with neonatal morphine solution or methadone being the most commonly used medications.”
Mothers who received buprenorphine, methadone or opioids during pregnancy gave permission to have their infants enrolled in the study by Davis and colleagues between Feb. 9, 2014, and March 6, 2017, at eight U.S. medical sites. One hundred and seventeen infants were randomly assigned to receive methadone or morphine.
Infants were treated with methadone or placebo every 4 hours or morphine every 4 hours. The researchers used the Finnegan Neonatal Abstinence Scoring System to measure progress. Infants with persistently elevated scores received increased doses. Phenobarbital was administered to infants who exceeded a predetermined opioid dose. If signs of NAS were reached, dose reductions by 10% occurred every 12 to 48 hours and were stopped at 20% of original dose. There was an observation period of 48 hours before infants were discharged.
Length of hospital stay (LOS) was the study’s primary endpoint.
Data on 116 infants were analyzed (mean gestational age, 39.1 weeks; mean birth weight 3157 g; 50% male) after one parent withdrew consent. Mothers of infants in the methadone treatment group were more likely to smoke, but other risk factors and variables were similar between the cohorts, according to the researchers.
When the researchers adjusted for treatment site and maternal opioid type, they found that methadone, when compared with morphine treatment, was associated with a 14% reduction in mean relative number of days for LOS (P = .046), a difference of 2.9 days; a 14% reduction in LOS attributable to NAS (P = .01), a difference of 2.7 days; and 16% reduction in the length of drug treatment, or LOT (P = .02), a difference of 2.3 days.
Reductions in median LOS of 16 days vs. 20 days (P = .05), LOS attributable to NAS of 16 days vs. 19 days (P =.005) and LOT of 11.5 days vs. 15 days (P = .009) were also associated with methadone treatment compared with morphine.
Beneficial results were found to be primarily attributed to methadone when short-term outcomes of study infants were compared with 170 infants who were not randomly assigned to treatment and who were treated with morphine using standardized weight-based protocols.
“Our study is the only multicenter comparison trial to date and suggests that the choice of opioid in infants with NAS can affect the duration of treatment independent of opioid exposure during pregnancy,” the researchers wrote.
“A more complete understanding of the factors that determine the severity of NAS and the long-term safety of different treatment approaches is needed,” they concluded.– by Bruce Thiel
Disclosures: The authors report no relevant financial disclosures.
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