Post-tonsillectomy Pain Control in Adults

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.

Conditions

• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Postoperative Hemorrhage
• Body Weight Changes

Interventions

DRUG

Norco (Hydrocodone and Acetaminophen)

Norco (Hydrocodone and Acetaminophen) 5/325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN (as needed) pain following Tonsillectomy for 14 days

DRUG

Percocet (Oxycodone and Acetaminophen)

Percocet (Oxycodone and Acetaminophen) 5/325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days

DRUG

Dilaudid (hydromorphone)

Dilaudid (hydromorphone) 2 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days

DRUG

Tylenol (Acetaminophen)

Tylenol (Acetaminophen) 325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days

Sponsors & Collaborators

• University of Nebraska

  lead OTHER

Principal Investigators

• Samuel Pate, M.D. · University of Nebraska Medical Center Department of Otolaryngology - Head and Neck Surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2019-01-24

Completion

2019-01-24

Countries

• United States

Study Locations