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Methadone Pharmacokinetics in End-stage Renal Disease

NCT06056245 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-05-10

No results posted yet for this study

Summary

The goal of this observational study is to describe the influence of renal function on the pharmacokinetics of methadone used through an intravenous patient-controlled analgesia (IV-PCA) pump for the management of acute postoperative pain. After surgery the participants will use an IV-PCA of methadone and blood samples will be withdrawn to measure the plasmatic levels of it.

The main question the study aims to answer is:

• Is the pharmacokinetic of methadone used in an IV-PCA pump impaired in patients with chronic kidney disease?

Conditions

  • Chronic Kidney Diseases
  • Post Operative Pain
  • Pain, Acute

Interventions

PROCEDURE

Preoperative step

* Explanation of the surgery and use of the IV-PCA pump. * Signed informed consent.

DRUG

Intraoperative

Bolus of methadone 0.1mg/kg based on ideal body weight (up to a maximum dose of 20 mg), at the beginning of surgery.

DRUG

Post-operative

Installation of IV-PCA of methadone. Program to be used with no background infusion, boluses of 1 mg, and the intervals between boluses of 8 minutes.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Eduardo Vega, MD · Pontificia Universidad Catolica de Chile

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-05
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Chile

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 NCT06056245 on ClinicalTrials.gov