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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 is a Phase 4 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 27 participants.

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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.

Interventions

  • DRUG Norco (Hydrocodone and Acetaminophen)
  • DRUG Percocet (Oxycodone and Acetaminophen)
  • DRUG Dilaudid (hydromorphone)
  • DRUG Tylenol (Acetaminophen)

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2016-01
Est. Completion 2019-01-24
Phase Phase 4

Sponsor

University of Nebraska

407 total trials

What the Registry Record Tells You About NCT02358850

The ClinicalTrials.gov registry entry for NCT02358850 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Norco (Hydrocodone and Acetaminophen) is the first listed.

NCT02358850 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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