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NCT01094522 · ClinicalTrials.gov registry record · Phase 1
Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT01094522: Completed Phase 1 study, sponsored by Stanford University.
NCT01094522 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 47 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01094522, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
Study Population: Neonates, infants and children from birth to 5 years of age undergoing cardiac surgery with CPB. The use of methadone to provide analgesia may be increasing due to advantages compared to other commonly used opioid analgesic drugs. While efficacy of methadone has been reported in adults, there is a paucity of information in neonates and infants. In the latter population, fentanyl and morphine are most commonly used for opioid analgesia following major surgery, while methadone is frequently used for weaning of opioid dependent and tolerant patients, in spite of the paucity of knowledge of methadone pharmacology in this population. There are several clinical problems associated with fentanyl and morphine, and methadone may offer superior efficacy with fewer side effects than these agents. We propose to study the pharmacokinetics (PK) and pharmacodynamics (PD) of methadone in neonates and infants in the intensive care unit following cardiac surgery.
Interventions
- DRUG Methadone
- DRUG Morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01094522
The ClinicalTrials.gov registry entry for NCT01094522 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Methadone is the first listed.
NCT01094522 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01094522 about?
NCT01094522 is a clinical study titled "Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.". Study Population: Neonates, infants and children from birth to 5 years of age undergoing cardiac surgery with CPB. The use of methadone to provide analgesia may be increasing due to advantages compared to other commonly used opioid analgesic drugs. While efficacy of methadone has been reported in ...
What is the current status of trial NCT01094522?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2010-03. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01094522?
The interventions under investigation include: Methadone (DRUG), Morphine (DRUG).
Who is sponsoring clinical trial NCT01094522?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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