Post-tonsillectomy Pain Control in Adults: a Randomized Prospective Study

0658-14-FB

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.

2016-01-01

2019-01-24

2019-01-24

Terminated

Early phase I

27

Inclusion Criteria: * 18 years and older * Surgical indications: Chronic tonsillitis, Snoring, Sleep apnea * Surgical procedure: Tonsillectomy with monopolar cautery, hemostasis with monopolar cautery and/or suction cautery. The surgical procedure can also include Adenoidectomy with suction cautery Exclusion Criteria: * Additional surgical procedures (i.e. UPPP (uvulopalatopharyngoplasty), septoplasty, inferior turbinate reduction) during same surgery * Pregnant females * Indications: Suspected malignancy * History of chronic pain or daily pain medication used for another medical problem * History of liver disease * Contraindications to preoperative Decadron * Contraindications to pain regimen medications (Tylenol, Norco, Percocet, Dilaudid)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 27, 'type': 'ACTUAL'}}

2023-07-13