AnesthesiaPhase 4NCT00921843
Methadone in Pediatric Anesthesia
A Phase 4 study testing Methadone 0.1mg/kg, Methadone 0.2mg/kg and Methadone 0.3mg/kg in people with Anesthesia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Methadone 0.1mg/kg, Methadone 0.2mg/kg and Methadone 0.3mg/kg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to May 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- History of or known liver or kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.
- Conditions
- Anesthesia
- Being tested
- Methadone 0.1mg/kg, Methadone 0.2mg/kg, Methadone 0.3mg/kg, Control
- Keywords
- Pediatric patients undergoing surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone 0.1mg/kgDrug
Subjects will receive methadone as their intraoperative opioid.
Methadone 0.2mg/kgDrug
Subjects will receive methadone as their intraoperative opioid.
Methadone 0.3mg/kgDrug
Subjects will receive methadone as their intraoperative opioid.
ControlDrug
Subjects will not receive methadone as their intraoperative opioid.
| Study group | Role | What they receive |
|---|---|---|
| Methadone 0.1mg/kg | Experimental | Methadone 0.1mg/kg Receives: Drug: Methadone 0.1mg/kg |
| Methadone 0.2mg/kg | Experimental | Methadone 0.2mg/kg Receives: Drug: Methadone 0.2mg/kg |
| Methadone 0.3mg/kg | Experimental | Methadone 0.3mg/kg Receives: Drug: Methadone 0.3mg/kg |
| Control | Placebo comparator | No methadone Receives: Drug: Methadone 0.2mg/kg; Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
R-methadone Plasma AUC 0-96hr/Dose
Measured: 96 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan Kharasch, Duke University
- Investigators
- Evan Kharasch, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921843
- Sponsor's protocol ID
- 08-1195
- Status last verified
- Apr 2019
- First submitted
- 10 Jun 2009
- Last updated
- 14 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone in Pediatric Anesthesia
- ClinicalTrials.gov ID
- NCT00921843
- Acronym / sponsor ID
- 08-1195
- Conditions
- Anesthesia
- Keywords
- Pediatric patients undergoing surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Posted 14 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Methadone 0.1mg/kg | Experimental | Drug: Methadone 0.1mg/kgMethadone 0.1mg/kg |
| Methadone 0.2mg/kg | Experimental | Drug: Methadone 0.2mg/kgMethadone 0.2mg/kg |
| Methadone 0.3mg/kg | Experimental | Drug: Methadone 0.3mg/kgMethadone 0.3mg/kg |
| Control | Placebo comparator | Drug: Methadone 0.2mg/kg, Drug: ControlNo methadone |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- History of or known liver or kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methadone 0.1mg/kgSubjects will receive methadone as their intraoperative opioid. | Drug | Methadone 0.1mg/kg |
| Methadone 0.2mg/kgSubjects will receive methadone as their intraoperative opioid. | Drug | Control, Methadone 0.2mg/kg |
| Methadone 0.3mg/kgSubjects will receive methadone as their intraoperative opioid. | Drug | Methadone 0.3mg/kg |
| ControlSubjects will not receive methadone as their intraoperative opioid. | Drug | Control |
Primary outcome
R-methadone Plasma AUC 0-96hr/Dose
Time frame: 96 hr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Kharasch, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methadone 0.1mg/kg, Methadone 0.2mg/kg and Methadone 0.3mg/kg in people with Anesthesia, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R-methadone Plasma AUC 0-96hr/Dose (time frame: 96 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019; AzTrials last refreshed its copy on 29 Oct 2026.