Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02358850
Study type Interventional
Source University of Nebraska
Contact
Status Terminated
Phase Phase 4
Start date January 2016
Completion date January 24, 2019

See also
  Status Clinical Trial Phase
Completed NCT05480111 - The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy Phase 4
Completed NCT06129305 - Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Completed NCT04401826 - Micro-surgical Treatment of Gummy Smile N/A
Recruiting NCT04020133 - the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction. N/A
Completed NCT03023462 - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair N/A
Completed NCT03546738 - Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery N/A
Completed NCT03652103 - Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy Phase 4
Withdrawn NCT03528343 - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy Phase 1/Phase 2
Terminated NCT03261193 - ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain Phase 3
Completed NCT02525133 - Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty Phase 3
Completed NCT03244540 - Regional Analgesia After Cesarean Section Phase 4
Enrolling by invitation NCT05316168 - Post Operative Pain Management for ACL Reconstruction Phase 3
Recruiting NCT04130464 - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management Phase 4
Enrolling by invitation NCT04574791 - Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty N/A
Completed NCT04073069 - Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults Phase 4
Completed NCT04526236 - Influence of Aging on Perioperative Methadone Dosing Phase 4
Recruiting NCT05351229 - Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery Phase 4
Enrolling by invitation NCT05543109 - Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block N/A
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04919317 - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty Phase 2