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NCT04037085 · ClinicalTrials.gov registry record · Phase 2
Ketamine to Improve Recovery After Cesarean Delivery - Part 1
A Phase 2 study, sponsored by Grace Lim, MD, MS.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT04037085 is a Phase 2 study that has completed, run by Grace Lim, MD, MS. The registered enrollment target is 8 participants.
The verdict
NCT04037085, a Phase 2 study, has completed, sponsored by Grace Lim, MD, MS.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1) and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine bolus-and-infusion strategy, as a preventive analgesic modality to reduce pain and opioid requirements. In Part 1, physiochemical analysis of pharmacokinetic/pharmacodynamic (PK/PD) and breastmilk transfer of ketamine and its metabolites will be assessed. Additionally calculated estimations for neonatal and infant exposure will be assessed. In Part 2, PK/PD assessments will continue in a larger cohort; endpoints will also include postpartum pain, depression scores, central sensitization measures, patient-reported postpartum recovery scores, breastfeeding, and parent-infant bonding, assessed in the acute post-cesarean period and up to 12 weeks postpartum in a randomized controlled trial.
Interventions
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2021-08-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04037085
The ClinicalTrials.gov registry entry for NCT04037085 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grace Lim, MD, MS, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ketamine is the first listed.
NCT04037085 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04037085 about?
NCT04037085 is a clinical study titled "Ketamine to Improve Recovery After Cesarean Delivery - Part 1". The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1) and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine bolus-and-infusion strategy, as a preventive analgesic modality to reduce pain and opioid requirements. In Part 1, physiochemical...
What is the current status of trial NCT04037085?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2019-10-09. Estimated completion is 2021-08-01.
What interventions are being tested in trial NCT04037085?
The interventions under investigation include: Ketamine (DRUG).
Who is sponsoring clinical trial NCT04037085?
This trial is sponsored by Grace Lim, MD, MS, which has 10 total clinical trials registered on ClinicalTrials.gov.
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