Post-tonsillectomy Pain Control in Adults



Status:Recruiting
Conditions:Obesity Weight Loss, Post-Surgical Pain, Hospital, Hospital
Therapuetic Areas:Endocrinology, Musculoskeletal, Other
Healthy:No
Age Range:18 - Any
Updated:10/22/2017
Start Date:January 2016
Contact:Mark A Miller, M.D.
Email:mark.miller@unmc.edu
Phone:402-559-7005

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

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.

Hypotheses

- There is an optimal pain control regimen for post-tonsillectomy pain control in adults

- Post-tonsillectomy pain levels in adults peak around postoperative day number seven

- Post-tonsillectomy adults return very slowly to normal (pre-surgery) oral intake and
diet

Purpose

- To assess daily post-tonsillectomy pain level in adults for the two weeks after surgery

- To determine if there is an optimal post-tonsillectomy pain control regimen in adults
for the two weeks after surgery

- To determine oral intake levels in post-tonsillectomy adults for the two weeks after
surgery

- To determine daily amounts of nausea/vomiting in post-tonsillectomy adults for the two
weeks after surgery

- To determine the change in weight in the two to three weeks after surgery

Study Background Tonsillectomy (with or without adenoidectomy) is a very common procedure in
children and adults. The most common indications for tonsillectomies include chronic
tonsillitis and/or obstructive sleep apnea. While many studies have examined the optimal
postoperative pain control regimen in children, the optimal pain control regimen in adults
remains poorly studied and understood.

Literature regarding post-tonsillectomy pain in adults has primarily focused on the specific
tonsillectomy surgical technique (there are many) rather than the exact medications used for
pain control. Interestingly, some of these aforementioned studies did not include the name,
type or quantity of pain medications given to their patients when the primary study endpoint
was pain. Additional studies have examined the role of steroids, antibiotics, and/or pain
medications given by Anesthesia while a patient is anesthetized and undergoing tonsillectomy
to determine if this can reduce postoperative pain. IV steroids given perioperatively to
adults undergoing tonsillectomy have less pain, nausea, and vomiting in the first few days
after tonsillectomy. IV steroids are now routinely given before tonsillectomy by most
practicing Otolaryngologists, including our senior authors.

There are a limited number of studies looking at actual postoperative pain control regimens
in adults. Most of these studies are limited in that they only looked at the first 24 hours
following surgery rather than trending pain levels for the first week or two after surgery.
Additional studies are limited because they are observational or prospective without
comparative pain regimen groups (i.e. they gave all patients the same medications asked them
their daily pain levels).

Furthermore, a majority of studies involving postoperative pain control used a "cold steel"
technique tonsillectomy, which is uncommonly practiced in the United States by
Otolaryngologists, who prefer the use of electrocautery devices for tonsillectomy. It is well
known and accepted that cautery causes more postoperative pain due to thermal tissue injury,
however it allows for a straightforward surgery with better intraoperative control of
bleeding. Furthermore, randomized prospective studies for postoperative pain control
following cautery tonsillectomy are lacking in the literature.

It is well known that the expected recovery period for adults is 2-4 weeks, during which they
cannot work or do any strenuous activity. We would argue that the first 24 hours after
tonsillectomy is actually better tolerated by adults because they have received high potency
narcotics (usually through their IV) during and right after surgery. Therefore a more
meaningful time period to study would be postoperative day number 1 - 14, when the patient is
at home and the pain is most severe (most patients state that their pain peaks around
postoperative number 5-7). Pain control is incredibly important issue in the
post-tonsillectomy patient. If they have too much pain, they will not drink or eat enough to
stay hydrated and nourished. This can lead to electrolyte abnormalities and dehydration
requiring visits to the Emergency Department with or without admission to the hospital.

The purpose of this study is to evaluate post-tonsillectomy pain control in adults using
three randomized medication regimens. All patients would undergo the same surgical technique
to avoid confounding variables. Surgeries would be performed by Otolaryngology - Head and
Neck Surgery Residents under the direct supervision of Otolaryngology staff attending
surgeons. All of the proposed pain regimens are commonly accepted regimens used by practicing
Otolaryngologists for adults.

Patients would be asked to complete a questionnaire that numerically evaluates their daily:
pain level, amount of oral intake, amount of nausea/vomiting, and amount of pain medications
used. They would asked to mail in their results or return the clinic. Additional information
would be collected from the patients and/or their medical records including visits to the
emergency department, readmissions to the hospital, and postoperative complications including
post-tonsillectomy bleeding. Data would be compiled and analyzed to determine the typical
postoperative pain levels, daily oral intake level, and to compare the different pain
regimens to determine if one is superior.

It is important to note that there are accepted risks of general anesthesia and undergoing
tonsillectomy with or without adenoidectomy. Participation in this study would not change any
of the accepted risk of undergoing the surgical procedure. The risks commonly discussed with
patients before tonsillectomy with or without adenoidectomy include failure to resolve
chronic throat infections, failure to resolve obstructive sleep apnea, voice changes after
surgery, damage to lips/teeth/tongue, taste changes, dehydration, need to return to the
emergency department, need for admission to the hospital, and 3-5% risk of post-tonsillectomy
bleeding that may result in need for additional surgical procedures and/or blood
transfusions.

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)
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