Phase 4
N=61
Methadone in Pediatric Anesthesia
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT00921843 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: R-methadone Plasma AUC 0-96hr/Dose — 228; 189; 205; 0 (ng * hr-1 * ml-1 * mg-1 — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methadone 0.1mg/kg (Drug); Methadone 0.2mg/kg (Drug); Methadone 0.3mg/kg (Drug); Control (Drug)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY R-methadone Plasma AUC 0-96hr/Dose |
228; 189; 205; 0 | <0.05 sig |
Summary
This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.
Eligibility Criteria
Inclusion Criteria
- Age 5-18
- Undergoing General anesthesia and surgery with anticipated postoperative inpatient stay of greater than or equal to 3 days
- Signed, written, informed consent from legal guardians and assent from patient
Exclusion Criteria
- History of or known liver or kidney disease
Data sourced from ClinicalTrials.gov (NCT00921843). 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.