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OpenTrials
Completed

NCT Number: NCT00921843

Methadone in Pediatric Anesthesia

This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.

Completed

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Key information

Conditions

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methadone 0.1mg/kg

Drug

Subjects will receive methadone as their intraoperative opioid.

Methadone 0.2mg/kg

Drug

Subjects will receive methadone as their intraoperative opioid.

Methadone 0.3mg/kg

Drug

Subjects will receive methadone as their intraoperative opioid.

Control

Drug

Subjects will not receive methadone as their intraoperative opioid.

Primary outcomes

  1. R-methadone Plasma AUC 0-96hr/Dose

    Time frame: 96 hr

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 16, 2009
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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