Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04246697 · ClinicalTrials.gov registry record · Phase 4
Multimodal Pain Study in Free Flap Patients
A Phase 4 study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT04246697 is a Phase 4 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 30 participants.
The verdict
NCT04246697, a Phase 4 study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will be a randomized, prospective study comparing Pain Management Arm A and Pain Management Arm B. Arm A will have scheduled Tylenol with opioids available as needed (PRN) in the peri-operative period. Arm B will undergo scheduled Gabapentin, Ketorolac and Tylenol as well as the Anesthesiology team managing regional nerve blocks, with opioids available PRN in the peri-operative period. The amount of pain medication used by all patients will be recorded as well as pain scores documented on a pain scale (0-10 with 0 indicating no pain and 10 indicating worst pain ever) as well as ABC pain scale throughout the patients' hospital stay. Morphine equivalents for the opioids will be calculated for each arm while observing pain scores. Then, the investigators will compare these two groups to see if there is a difference in opioid pain medication used. The study team's hypothesis is that the use of Gabapentin, Ketorolac, and Tylenol in combination will significantly reduce (at least 30% of Mean Morphine Equivalents - MME) the use of opioid medication for patients undergoing head and neck free flap reconstruction with similar to improved pain scores.
Interventions
- DRUG Tylenol
- DRUG Oxycodone
- DRUG Gabapentin
- DRUG Morphine
- DRUG toradol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2023-05-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04246697
The ClinicalTrials.gov registry entry for NCT04246697 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Tylenol is the first listed.
NCT04246697 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04246697 about?
NCT04246697 is a clinical study titled "Multimodal Pain Study in Free Flap Patients". This study will be a randomized, prospective study comparing Pain Management Arm A and Pain Management Arm B. Arm A will have scheduled Tylenol with opioids available as needed (PRN) in the peri-operative period. Arm B will undergo scheduled Gabapentin, Ketorolac and Tylenol as well as the Anesthesi...
What is the current status of trial NCT04246697?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2019-11-01. Estimated completion is 2023-05-01.
What interventions are being tested in trial NCT04246697?
The interventions under investigation include: Tylenol (DRUG), Oxycodone (DRUG), Gabapentin (DRUG), Morphine (DRUG), toradol (DRUG).
Who is sponsoring clinical trial NCT04246697?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.