NCT00921843

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
8 years until next milestone

Results Posted

Study results publicly available

May 14, 2019

Completed
Last Updated

May 14, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

June 10, 2009

Results QC Date

June 18, 2018

Last Update Submit

April 19, 2019

Conditions

Anesthesia

Keywords

Pediatric patients undergoing surgery

Outcome Measures

Primary Outcomes (1)

  • R-methadone Plasma AUC 0-96hr/Dose

    96 hr

Study Arms (4)

Methadone 0.1mg/kg

EXPERIMENTAL

Methadone 0.1mg/kg

Drug: Methadone 0.1mg/kg

Methadone 0.2mg/kg

EXPERIMENTAL

Methadone 0.2mg/kg

Drug: Methadone 0.2mg/kg

Methadone 0.3mg/kg

EXPERIMENTAL

Methadone 0.3mg/kg

Drug: Methadone 0.3mg/kg

Control

PLACEBO COMPARATOR

No methadone

Drug: Methadone 0.2mg/kgDrug: Control

Interventions

Methadone 0.1mg/kgDRUG

Subjects will receive methadone as their intraoperative opioid.

Methadone 0.1mg/kg
Methadone 0.2mg/kgDRUG

Subjects will receive methadone as their intraoperative opioid.

ControlMethadone 0.2mg/kg
Methadone 0.3mg/kgDRUG

Subjects will receive methadone as their intraoperative opioid.

Methadone 0.3mg/kg
ControlDRUG

Subjects will not receive methadone as their intraoperative opioid.

Control

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History of or known liver or kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Interventions

Methadone

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Results Point of Contact

Title
Evan Kharasch MD PhD
Organization
Washington University
kharasch@wustl.edu
3143628796

Study Officials

  • Evan Kharasch, MD, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-Chair for Innovation, Director of Research Entrepreneurship

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 16, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 14, 2019

Results First Posted

May 14, 2019

Record last verified: 2019-04

Locations

US(1)