On January 10, 2014, the site team at the Medical University of South Carolina enrolled the first patient into the “Pharmacokinetics of Multiple-dose Methadone in Children” study. Andrew Atz, MD, principal investigator, Hibah Al Nasiri, study coordinator, and Patricia Infinger, research manager, oversee the team at this institution.

This multicenter study will determine the pharmacokinetics of enteral methadone in children treated for opiate withdrawal. Critically ill children routinely receive opioids for analgesia and sedation to reduce pain and stress, facilitate ventilation, and avoid secondary complications. Continuous infusions of opioids can result in tolerance, however, frequently leading to withdrawal symptoms if the drugs are discontinued abruptly. Opioid withdrawal is a major problem in the pediatric intensive care unit, where it is estimated to occur in up to 57% of patients.

Fortunately, gradual opioid tapering is possible with drugs such as methadone, which can be substituted for narcotic infusions during the weaning process to prevent withdrawal symptoms. Methadone is commonly prescribed to hospitalized children, particularly in younger age groups. We know that methadone levels in the blood vary dramatically in adults, especially after oral administration. That is likely to be the case in children, but there are virtually no studies to guide dosing in this younger population.

The study will enroll children aged >90 days to <18 years of age who are prescribed methadone per routine care. As many as 36 participants will be enrolled at up to 5 sites. Visit clinicaltrials.gov for more information.