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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). 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 |
What the finished NCT01094522 record still lists
NCT01094522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Methadone is the first listed.
NCT01094522 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01094522's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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