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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: Clinical Trial Phase 4 study, sponsored by St. Louis University.
NCT03677830 is a Phase 4 study that was terminated before completion, run by St. Louis University. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Total amount of morphine received by infants for pain control post-operatively in mg/kg
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 |
Why NCT03677830 stopped before completion
NCT03677830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Acetaminophen is the first listed.
NCT03677830 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03677830's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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