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Epidural Methadone in Healthy Volunteers

NCT03525509 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-09-18

No results posted yet for this study

Summary

Epidurally administered opioid pain medications are important tools for postoperative pain control, but each agent has its own limitations. Methadone's properties suggest that it may provide a long duration of pain control with minimal side effects related to spread to the brain or absorption into the blood stream. In this study, the investigators aim to compare the relative pain relieving effects, markers of side effects, and concentrations in the blood of epidurally administered methadone as compared to another long-acting opioid which is commonly administered epidurally, morphine.

Conditions

  • Pain, Acute

Interventions

DRUG

Methadone hydrochloride

Epidural bolus of 4mg of preservative free methadone hydrochloride (4mL of 1mg/mL solution)

DRUG

Morphine Sulfate

Epidural bolus of 4mg of preservative free morphine sulfate (4mL of 1mg/mL solution)

Sponsors & Collaborators

  • simon.haroutounian

    lead OTHER

Principal Investigators

  • Simon Haroutounian, PhD · Washington University in Saint Louis

  • Yehuda Ginosar, MBBS · Washington University in Saint Louis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2019-08-28
Completion
2019-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03525509 on ClinicalTrials.gov