drugset / Trial / NCT02358850

Post-tonsillectomy Pain Control in Adults

NCT02358850

Phase 4 Terminated 27 enrolled University of Nebraska
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2016-01
Primary completion
2019-01-24
Completion
2019-01-24

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 325 mg Oral
Comparator Hydrocodone Unknown 5 mg Oral
Comparator Hydromorphone Other / unclassified 2 mg Oral
Comparator Oxycodone Other / unclassified 5 mg Oral

Indications