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Post-tonsillectomy Pain Control in Adults

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ClinicalTrials.gov Identifier: NCT02358850
Recruitment Status : Recruiting
First Posted : February 9, 2015
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Samuel Pate MD, University of Nebraska

Tracking Information
First Submitted Date  ICMJE January 14, 2015
First Posted Date  ICMJE February 9, 2015
Last Update Posted Date October 20, 2017
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • Daily pain level [ Time Frame: Postoperative day 1 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 2 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 3 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 4 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 5 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 6 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 7 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 8 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 9 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 10 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 11 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 12 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 13 ]
    Daily pain level on scale from 0-10
  • Daily pain level [ Time Frame: Postoperative day 14 ]
    Daily pain level on scale from 0-10
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02358850 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • Daily oral liquid intake [ Time Frame: Postoperative day 1 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 2 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 3 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 4 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 5 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 6 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 7 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 8 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 9 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 10 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 11 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 12 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 13 ]
    Daily estimation of cups of liquids consumed
  • Daily oral liquid intake [ Time Frame: Postoperative day 14 ]
    Daily estimation of cups of liquids consumed
  • Daily nausea/vomiting [ Time Frame: Postoperative day 1 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 2 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 3 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 4 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 5 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 6 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 7 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 8 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 9 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 10 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 11 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 12 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 13 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Daily nausea/vomiting [ Time Frame: Postoperative day 14 ]
    Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
    1. = mild nausea
    2. = significant nausea and/or dry heaving
    3. = vomiting
  • Weight Change from Baseline [ Time Frame: Preoperative weight compared to postoperative weight at 2-3 weeks after surgery ]
    Weight change comparing preoperative weight (kg) to postoperative weight (kg) at 2-3 weeks after surgery
  • Visit to emergency department after surgery [ Time Frame: Within 14 days after surgery ]
    Yes/No answer for if patient needed to visit the emergency department after surgery for any reason related to their surgery
  • Post tonsillectomy hemorrhage [ Time Frame: Within 14 days after surgery ]
    If patient had a post tonsillectomy hemorrhage and if any treatment was needed
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-tonsillectomy Pain Control in Adults
Official Title  ICMJE Post-tonsillectomy Pain Control in Adults: a Randomized Prospective Study
Brief 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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Postoperative
  • Postoperative Nausea and Vomiting
  • Postoperative Hemorrhage
  • Body Weight Changes
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Tonsillectomy and Norco
    This represents patients who will be randomized (1:3 chance) to postoperative pain control with Norco (Hydrocodone and Acetaminophen)
    Intervention: Drug: Norco (Hydrocodone and Acetaminophen)
  • Active Comparator: Tonsillectomy and Percocet
    This represents patients who will be randomized (1:3 chance) to postoperative pain control with Percocet (Oxycodone and Acetaminophen)
    Intervention: Drug: Percocet (Oxycodone and Acetaminophen)
  • Active Comparator: Tonsillectomy and Dilaudid + Tylenol
    This represents patients who will be randomized (1:3 chance) to postoperative pain control with Dilaudid (hydromorphone) and Tylenol (Acetaminophen)
    Interventions:
    • Drug: Dilaudid (hydromorphone)
    • Drug: Tylenol (Acetaminophen)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2015)
39
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mark A Miller, M.D. 402-559-7005 mark.miller@unmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02358850
Other Study ID Numbers  ICMJE 658-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samuel Pate MD, University of Nebraska
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samuel Pate, M.D. University of Nebraska Medical Center Department of Otolaryngology - Head and Neck Surgery
PRS Account University of Nebraska
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP