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NCT04528173 · ClinicalTrials.gov registry record · Phase 4
Opioid-Free Anesthetic for Tonsillectomy
A Phase 4 study, sponsored by Children's Hospital of Philadelphia.
- Terminated
- Registry status
- Phase 4
- Development phase
- 35
- Enrollment target
NCT04528173: Clinical Trial Phase 4 study, sponsored by Children's Hospital of Philadelphia.
NCT04528173 is a Phase 4 study that was terminated before completion, run by Children's Hospital of Philadelphia. The registered enrollment target is 35 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04528173, a Phase 4 study, was terminated before completion, sponsored by Children's Hospital of Philadelphia.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 35 participants
- Enrollment target
Study Summary
Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic
Primary Outcome
Mean FLACC pain assessment scores are calculated 15 and 30 minutes after awakening, Scores are calculated by a blinded study team observer. Minimum Score: 0 and Maximum Score: 10. Higher scores indicate worse outcomes. One Nursing Maximum FLACC pain score is obtained by an unblinded patient Registered Nurse (RN) during the patient's Post-Anesthesia Care Unit (PACU) stay within one hour of awakening. The pain score is collected from the nursing documentation in the electronic medical record. FLA
Interventions
- DRUG Ketorolac
- DRUG Dexmedetomidine
- DRUG Morphine
- DRUG Fentanyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-07-22 |
| Est. Completion | 2023-08-22 |
| Phase | Phase 4 |
Why NCT04528173 stopped before completion
NCT04528173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 4 interventions - of which Ketorolac is the first listed.
NCT04528173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04528173 about?
NCT04528173 is a clinical study titled "Opioid-Free Anesthetic for Tonsillectomy". Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic
What is the current status of trial NCT04528173?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2020-07-22. Estimated completion is 2023-08-22.
What interventions are being tested in trial NCT04528173?
The interventions under investigation include: Ketorolac (DRUG), Dexmedetomidine (DRUG), Morphine (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT04528173?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04528173's enrollment target sits among peer trials
35 1506th of 2000 higher than 481 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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