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NCT03677830 · ClinicalTrials.gov registry record · Phase 4
Postoperative Pain Control & Relief in Neonates
A Phase 4 study, sponsored by St. Louis University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT03677830 is a Phase 4 study that was terminated before completion, run by St. Louis University. The registered enrollment target is 11 participants.
The verdict
NCT03677830, a Phase 4 study, was terminated before completion, sponsored by St. Louis University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
Pain control for newborns has made significant improvements over the last 30 years. The use of narcotics remains the standard of care for neonates undergoing minor and major surgeries. Narcotics, however, are associated with adverse effects such as respiratory depression, prolonged intubation and withdrawal symptoms. Acetaminophen (Tylenol©) has been proposed as an adjunct to reduce narcotic use but current evidence from well designed studies in newborns and premature infants is limited. This study will randomly assign neonates undergoing a surgery to either morphine plus acetaminophen or morphine alone for pain control. The subjects will be followed for 72 hours after the operation and evaluate the benefits of acetaminophen for pain control.
Interventions
- DRUG Acetaminophen
- DRUG Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-04-19 |
| Est. Completion | 2024-03-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03677830
The ClinicalTrials.gov registry entry for NCT03677830 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Acetaminophen is the first listed.
NCT03677830 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03677830 about?
NCT03677830 is a clinical study titled "Postoperative Pain Control & Relief in Neonates". Pain control for newborns has made significant improvements over the last 30 years. The use of narcotics remains the standard of care for neonates undergoing minor and major surgeries. Narcotics, however, are associated with adverse effects such as respiratory depression, prolonged intubation and wi...
What is the current status of trial NCT03677830?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2019-04-19. Estimated completion is 2024-03-07.
What interventions are being tested in trial NCT03677830?
The interventions under investigation include: Acetaminophen (DRUG), Saline (DRUG).
Who is sponsoring clinical trial NCT03677830?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
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