Methadone in Pediatric Anesthesiology II

Randomized, controlled, modified dose-escalation design. Patients receive standard monitoring
for anesthesia and postoperative care. Surgical and anesthesia (except for opioid use) care
are not altered for study purposes. All patients are induced by propofol and muscle
relaxants. In the first cohort (n=30 evaluable), subjects are randomized 1:2 to either
control (standard intraop opioid at anesthesiologists' discretion) or methadone HCl (0.4
mg/kg ideal body weight, IBW). In the second cohort (n=30 evaluable), subjects are randomized
1:2 to either control (standard intraop opioid) or methadone HCl (0.5 mg/kg ideal body
weight, IBW). Subjects in the study groups will receive methadone (IV bolus, after induction
of anesthesia) as their primary intraoperative opioid, rather than leaving the choice of
intraoperative opioid to the anesthesiologist. Intraoperative breakthrough pain will be
treated at the discretion of the anesthesiologist with fentanyl. In the control groups,
intraoperative opioid administration will be left at the discretion of the anesthesia
providers. Patient controlled analgesia as prescribed by the clinical team, using
hydromorphone or morphine, will be used to treat postoperative pain relief.

Inclusion Criteria.

- Age 11-18 years

- Undergoing general anesthesia and idiopathic posterior spinal surgery with anticipated
postop inpatient stay of > 3 days

- Signed, written, informed consent from legal guardians and assent from patient

Exclusion Criteria.

- History of or known liver or kidney disease.

- Females who are pregnant or nursing.

- Children with developmental delay

- Children undergoing surgery for scoliosis of musculoskeletal origin