Methadone in Pediatric Anesthesiology II (MEPAII)

The Washington University

Status: Completed

Conditions: Pain

Treatments: Drug: 0.3mg/kg IV methadone HCl; Other: control no methadone; Drug: 0.4mg/kg IV methadon HCl

Study type: Interventional

Funder types: Other

Identifiers

NCT01990573

201302099

Details and patient eligibility

About

Three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the pharmacokinetics of IV methadone in children (0.3 and 0.4 mg/kg).

Full description

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 (0.3 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.

Enrollment: 51 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 3 patient groups

methadone HCl 0.3 mg/kg

Experimental group

Description:

0.3mg/kg IV methadone HCl

Treatment:

Drug: 0.3mg/kg IV methadone HCl

methadone HCl 0.4 mg/kg

Experimental group

Description:

0.4mg/kg IV methadon HCl

Treatment:

Drug: 0.4mg/kg IV methadon HCl

control group

Active Comparator group

Description:

control no methadone, standard of care opioids.

Treatment:

Other: control no methadone