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NCT02358850 · ClinicalTrials.gov registry record · Phase 4
Post-tonsillectomy Pain Control in Adults
A Phase 4 study, sponsored by University of Nebraska.
- Terminated
- Registry status
- Phase 4
- Development phase
- 27
- Enrollment target
NCT02358850: Clinical Trial Phase 4 study, sponsored by University of Nebraska.
NCT02358850 is a Phase 4 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 27 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02358850, a Phase 4 study, was terminated before completion, sponsored by University of Nebraska.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is a randomized prospective study to determine the optimal postoperative pain medication regimen for adults (18 years old and older) undergoing tonsillectomy with or without adenoidectomy for chronic tonsillitis and/or snoring and/or obstructive sleep apnea. All participants will undergo the same tonsillectomy surgical technique (with or without adenoidectomy) under general anesthesia and be randomized to one of three postoperative pain control regimens (all of which are commonly used pain medications for post-tonsillectomy pain): 1. Norco (Hydrocodone and Acetaminophen) 2. Percocet (Oxycodone and Acetaminophen) 3. Dilaudid and Tylenol (Acetaminophen) Participants will be discharged home the day of surgery and will be sent home with questionnaires to assess their daily pain level, oral intake, amount of nausea/vomiting, and amount of pain medications taken for the 14 days following their surgery. Data will be collected and analyzed to determine if there is a difference in pain levels or oral intake or nausea/vomiting in the different pain regimen groups. Secondary endpoints will include weight change from preoperative weight to weight at 2-3 weeks after surgery in addition to postoperative complications including visits to the Emergency Department and post-tonsillectomy bleed rates. Participants will be seen 1-2 weeks following their surgery in the ENT (Ear, Nose and Throat) clinic per normal postoperative protocol and will not require any specific clinic visits related to this study.
Primary Outcome
Daily pain level on scale from 0-10
Interventions
- DRUG Norco (Hydrocodone and Acetaminophen)
- DRUG Percocet (Oxycodone and Acetaminophen)
- DRUG Dilaudid (hydromorphone)
- DRUG Tylenol (Acetaminophen)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-01-24 |
| Phase | Phase 4 |
Why NCT02358850 stopped before completion
NCT02358850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Norco (Hydrocodone and Acetaminophen) is the first listed.
NCT02358850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02358850 about?
NCT02358850 is a clinical study titled "Post-tonsillectomy Pain Control in Adults". This is a randomized prospective study to determine the optimal postoperative pain medication regimen for adults (18 years old and older) undergoing tonsillectomy with or without adenoidectomy for chronic tonsillitis and/or snoring and/or obstructive sleep apnea. All participants will undergo the sa...
What is the current status of trial NCT02358850?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2016-01. Estimated completion is 2019-01-24.
What interventions are being tested in trial NCT02358850?
The interventions under investigation include: Norco (Hydrocodone and Acetaminophen) (DRUG), Percocet (Oxycodone and Acetaminophen) (DRUG), Dilaudid (hydromorphone) (DRUG), Tylenol (Acetaminophen) (DRUG).
Who is sponsoring clinical trial NCT02358850?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02358850's enrollment target sits among peer trials
27 1651st of 2000 higher than 346 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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