N/A
Completed N=51
Methadone in Pediatric Anesthesiology II
Source: ClinicalTrials.gov NCT01990573 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Total Opioid Consumption (Morphine Equivalent) — 2.22; 2.37; 3.28 mg/kg — p=.002
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Consumption (Morphine Equivalent) |
2.22; 2.37; 3.28 | .002 sig |
| PRIMARY Pain Scores |
4.7; 4.6; 4.5 | .962 |
| SECONDARY Cmax of R and S Methadone |
97; 175; 127; 226 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01990573). 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. Informational only — not medical advice.