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NCT04149964 · ClinicalTrials.gov registry record · Phase 4
Postoperative Pain Control in Septum and Sinus Surgery
A Phase 4 study of Postoperative Pain and Sinus Surgery, sponsored by Corewell Health East.
- Completed
- Registry status
- Phase 4
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT04149964: Completed Phase 4 study of Postoperative Pain and Sinus Surgery, sponsored by Corewell Health East.
NCT04149964 is a Phase 4 study of Postoperative Pain and Sinus Surgery that has completed, run by Corewell Health East. The registered enrollment target is 65 participants, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04149964, a Phase 4 study of Postoperative Pain and Sinus Surgery, has completed, sponsored by Corewell Health East.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will lead to less opiate use in the first week post-operative (after surgery) in sinus/septum surgery patients. Participants will be randomized like a flip of a coin to either the standard of care pain treatment of acetaminophen 325 mg as needed for pain plus opiates (acetaminophen/hydrocodone) as needed for breakthrough pain; OR to the study arm of acetaminophen 650 mg every 6 hours plus opiates (Oxycodone)as needed for breakthrough pain.
Primary Outcome
Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week.
Conditions Studied
Interventions
- DRUG OxyCODONE 5 mg Oral Tablet
- DRUG Acetaminophen 650 mg Oral Tablet
- DRUG Acetaminophen 325 mg Oral Tablet
- DRUG Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet
Study Locations (1)
Michigan
- Beaumont Hospital - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2019-11-27 |
| Est. Completion | 2022-09-21 |
| Phase | Phase 4 |
What the finished NCT04149964 record still lists
NCT04149964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Postoperative Pain appearing as the primary indexed condition, and to 4 interventions - of which OxyCODONE 5 mg Oral Tablet is the first listed.
NCT04149964 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04149964 about?
NCT04149964 is a clinical study titled "Postoperative Pain Control in Septum and Sinus Surgery". This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will lead to less opiate use in the first week post-operative (after surgery) in sinus/septum surgery patients. Participants will be randomized like a flip of a coin to either the standard of care pain treatment o...
What is the current status of trial NCT04149964?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2019-11-27. Estimated completion is 2022-09-21.
What conditions does trial NCT04149964 study?
This clinical trial studies the following conditions: Postoperative Pain, Sinus Surgery.
What interventions are being tested in trial NCT04149964?
The interventions under investigation include: OxyCODONE 5 mg Oral Tablet (DRUG), Acetaminophen 650 mg Oral Tablet (DRUG), Acetaminophen 325 mg Oral Tablet (DRUG), Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet (DRUG).
Who is sponsoring clinical trial NCT04149964?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04149964 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04149964's enrollment target sits among peer trials
65 94th of 120 higher than 27 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain 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.
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