Phase 2 N=40 Randomized Quadruple-blind Treatment

Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.

Pain

Bottom Line

View on ClinicalTrials.gov: NCT01094522 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Aug 2017

Primary outcome: Primary: Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide) — 27.55; 225; 22.95 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Methadone (Drug); Morphine (Drug)
Age: Pediatric
Sex: All
Sponsor: Stanford University
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide)	27.55; 225; 22.95	—
PRIMARY Maximum Concentration of Methadone Including Its Metabolites (EDDP and EMDP)	52.35; 3.42; 0.194	—
SECONDARY •Pain Scores (FLACC) During the 24 Hours Study Period	1.375; 1.917	—
SECONDARY •Amount of Study Drug Administered During the 24-hour Dosing Period	8.56; 13.77	—

Summary

Study Population: Neonates, infants and children from birth to 5 years of age undergoing cardiac surgery with CPB. The use of methadone to provide analgesia may be increasing due to advantages compared to other commonly used opioid analgesic drugs. While efficacy of methadone has been reported in adults, there is a paucity of information in neonates and infants. In the latter population, fentanyl and morphine are most commonly used for opioid analgesia following major surgery, while methadone is frequently used for weaning of opioid dependent and tolerant patients, in spite of the paucity of knowledge of methadone pharmacology in this population. There are several clinical problems associated with fentanyl and morphine, and methadone may offer superior efficacy with fewer side effects than these agents. We propose to study the pharmacokinetics (PK) and pharmacodynamics (PD) of methadone in neonates and infants in the intensive care unit following cardiac surgery.

Eligibility Criteria

Inclusion Criteria

Neonates, infants and children from birth through 5 years of age undergoing mechanical ventilation following cardiac surgery for congenital heart disease. Congenital heart lesions include "two ventricle repairs", including tetralogy of Fallot, transposition of the great arteries, "unobstructed" total anomalous pulmonary venous return, truncus arteriosus, atrioventricular canal defect and ventricular septal defect.

Exclusion Criteria

Subjects will be excluded from the study because of prematurity (gestational age 2, AST/ALT > 200 IU/L), significant renal dysfunction (serum Cr > 1.5 mg/dL), participation within 30 days of study entry or within 5 times the half-life, whichever is longer, in another investigational drug study, or previous participation in this study. Patients will be excluded if they have received opioids for more than 12 hours of the 48-hour period prior to surgery. In addition, patients will be excluded if they have a history of other clinically significant medical problems, which, in the opinion of the investigator, would interfere with study participation.

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Data sourced from ClinicalTrials.gov (NCT01094522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.