Pain, PostoperativePhase 4NCT02358850
Post-tonsillectomy Pain Control in Adults
A Phase 4 study testing Norco (Hydrocodone and Acetaminophen), Percocet (Oxycodone and Acetaminophen) and Dilaudid (hydromorphone) in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by University of Nebraska at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Hemorrhage
- What is being tested?
- Norco (Hydrocodone and Acetaminophen), Percocet (Oxycodone and Acetaminophen) and Dilaudid (hydromorphone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 24 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: 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):
- Norco (Hydrocodone and Acetaminophen)
- Percocet (Oxycodone and Acetaminophen)
- Dilaudid and Tylenol (Acetaminophen)
Read more
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.
Read the 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.
- Conditions
- Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Hemorrhage, Body Weight Changes
- Being tested
- Norco (Hydrocodone and Acetaminophen), Percocet (Oxycodone and Acetaminophen), Dilaudid (hydromorphone), Tylenol (Acetaminophen)
- Keywords
- Tonsillectomy, Adenoidectomy
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Hemorrhage, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norco (Hydrocodone and Acetaminophen)Drug
Also called Norco
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
Percocet (Oxycodone and Acetaminophen)Drug
Also called Percocet
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
Dilaudid (hydromorphone)Drug
Also called Dilaudid
Dilaudid (hydromorphone) 2 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days
Tylenol (Acetaminophen)Drug
Also called Tylenol
Tylenol (Acetaminophen) 325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Tonsillectomy and Norco | Active comparator | This represents patients who will be randomized (1:3 chance) to postoperative pain control with Norco (Hydrocodone and Acetaminophen) Receives: Drug: Norco (Hydrocodone and Acetaminophen) |
| Tonsillectomy and Percocet | Active comparator | This represents patients who will be randomized (1:3 chance) to postoperative pain control with Percocet (Oxycodone and Acetaminophen) Receives: Drug: Percocet (Oxycodone and Acetaminophen) |
| Tonsillectomy and Dilaudid + Tylenol | Active comparator | This represents patients who will be randomized (1:3 chance) to postoperative pain control with Dilaudid (hydromorphone) and Tylenol (Acetaminophen) Receives: Drug: Dilaudid (hydromorphone); Drug: Tylenol (Acetaminophen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 1
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 2
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 3
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 4
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 5
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 6
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 7
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 8
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 9
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 10
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 11
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 12
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 13
Daily pain level
Daily pain level on scale from 0-10
Measured: Postoperative day 14
Secondary outcomes (31)
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 1
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 2
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 3
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 4
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 5
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 6
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 7
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 8
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 9
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 10
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 11
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 12
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 13
Daily oral liquid intake
Daily estimation of cups of liquids consumed
Measured: Postoperative day 14
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 1
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 2
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 3
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 4
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 5
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 6
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 7
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 8
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 9
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 10
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 11
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 12
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 13
Daily nausea/vomiting
Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea
- = mild nausea
- = significant nausea and/or dry heaving
- = vomiting
Measured: Postoperative day 14
Weight Change from Baseline
Weight change comparing preoperative weight (kg) to postoperative weight (kg) at 2-3 weeks after surgery
Measured: Preoperative weight compared to postoperative weight at 2-3 weeks after surgery
Visit to emergency department after surgery
Yes/No answer for if patient needed to visit the emergency department after surgery for any reason related to their surgery
Measured: Within 14 days after surgery
Post tonsillectomy hemorrhage
If patient had a post tonsillectomy hemorrhage and if any treatment was needed
Measured: Within 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startJan 2016
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Pate, M.D., Principal investigator, University of Nebraska Medical Center Department of Otolaryngology - Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358850
- Sponsor's protocol ID
- 0658-14-FB
- Status last verified
- Jul 2023
- First submitted
- 14 Jan 2015
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee SW, Jeon SS, Lee JD, Lee JY, Kim SC, Koh YW. A comparison of postoperative pain and complications in tonsillectomy using BiClamp forceps and electrocautery tonsillectomy. Otolaryngol Head Neck Surg. 2008 Aug;139(2):228-34. doi: 10.1016/j.otohns.2008.04.004.
PubMed 18656720Parsons SP, Cordes SR, Comer B. Comparison of posttonsillectomy pain using the ultrasonic scalpel, coblator, and electrocautery. Otolaryngol Head Neck Surg. 2006 Jan;134(1):106-13. doi: 10.1016/j.otohns.2005.09.027.
PubMed 16399189Noordzij JP, Affleck BD. Coblation versus unipolar electrocautery tonsillectomy: a prospective, randomized, single-blind study in adult patients. Laryngoscope. 2006 Aug;116(8):1303-9. doi: 10.1097/01.mlg.0000225944.00189.e9.
PubMed 16885729Diakos EA, Gallos ID, El-Shunnar S, Clarke M, Kazi R, Mehanna H. Dexamethasone reduces pain, vomiting and overall complications following tonsillectomy in adults: a systematic review and meta-analysis of randomised controlled trials. Clin Otolaryngol. 2011 Dec;36(6):531-42. doi: 10.1111/j.1749-4486.2011.02373.x.
PubMed 21812940Thorneman G, Akervall J. Pain treatment after tonsillectomy: advantages of analgesics regularly given compared with analgesics on demand. Acta Otolaryngol. 2000 Oct;120(8):986-9. doi: 10.1080/00016480050218744.
PubMed 11200596Naesh O, Niles LA, Gilbert JG, Ammar MM, Phibbs PW, Phillips AM, Khrapov AV, Robert AJ, McClintock A. A randomized, placebo-controlled study of rofecoxib with paracetamol in early post-tonsillectomy pain in adults. Eur J Anaesthesiol. 2005 Oct;22(10):768-73. doi: 10.1017/s0265021505001274.
PubMed 16211736Hiller A, Silvanto M, Savolainen S, Tarkkila P. Propacetamol and diclofenac alone and in combination for analgesia after elective tonsillectomy. Acta Anaesthesiol Scand. 2004 Oct;48(9):1185-9. doi: 10.1111/j.1399-6576.2004.00473.x.
PubMed 15352967Salonen A, Kokki H, Nuutinen J. Recovery after tonsillectomy in adults: a three-week follow-up study. Laryngoscope. 2002 Jan;112(1):94-8. doi: 10.1097/00005537-200201000-00017.
PubMed 11802045Ashbach MN, Ostrower ST, Parikh SR. Tonsillectomy techniques and pain: a review of randomized controlled trials and call for standardization. ORL J Otorhinolaryngol Relat Spec. 2007;69(6):364-70. doi: 10.1159/000108369. Epub 2007 Nov 23.
PubMed 18033974
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-tonsillectomy Pain Control in Adults: a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT02358850
- Acronym / sponsor ID
- 0658-14-FB
- Conditions
- Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Hemorrhage, Body Weight Changes
- Keywords
- Tonsillectomy, Adenoidectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Norco (Hydrocodone and Acetaminophen)
- Percocet (Oxycodone and Acetaminophen)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tonsillectomy and Norco | Active comparator | Drug: Norco (Hydrocodone and Acetaminophen)This represents patients who will be randomized (1:3 chance) to postoperative pain control with Norco (Hydrocodone and Acetaminophen) |
| Tonsillectomy and Percocet | Active comparator | Drug: Percocet (Oxycodone and Acetaminophen)This represents patients who will be randomized (1:3 chance) to postoperative pain control with Percocet (Oxycodone and Acetaminophen) |
| Tonsillectomy and Dilaudid + Tylenol | Active comparator | Drug: Dilaudid (hydromorphone), Drug: Tylenol (Acetaminophen)This represents patients who will be randomized (1:3 chance) to postoperative pain control with Dilaudid (hydromorphone) and Tylenol (Acetaminophen) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norco (Hydrocodone and Acetaminophen)Also: NorcoNorco (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 | Tonsillectomy and Norco |
| Percocet (Oxycodone and Acetaminophen)Also: PercocetPercocet (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 | Tonsillectomy and Percocet |
| Dilaudid (hydromorphone)Also: DilaudidDilaudid (hydromorphone) 2 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days | Drug | Tonsillectomy and Dilaudid + Tylenol |
| Tylenol (Acetaminophen)Also: TylenolTylenol (Acetaminophen) 325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days | Drug | Tonsillectomy and Dilaudid + Tylenol |
Primary outcome
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
31 secondary outcomes
Daily oral liquid intake
Time frame: Postoperative day 1
Daily oral liquid intake
Time frame: Postoperative day 2
Daily oral liquid intake
Time frame: Postoperative day 3
Daily oral liquid intake
Time frame: Postoperative day 4
Daily oral liquid intake
Time frame: Postoperative day 5
Daily oral liquid intake
Time frame: Postoperative day 6
Daily oral liquid intake
Time frame: Postoperative day 7
Daily oral liquid intake
Time frame: Postoperative day 8
Daily oral liquid intake
Time frame: Postoperative day 9
Daily oral liquid intake
Time frame: Postoperative day 10
Daily oral liquid intake
Time frame: Postoperative day 11
Daily oral liquid intake
Time frame: Postoperative day 12
Daily oral liquid intake
Time frame: Postoperative day 13
Daily oral liquid intake
Time frame: Postoperative day 14
Daily nausea/vomiting
Time frame: Postoperative day 1
Daily nausea/vomiting
Time frame: Postoperative day 2
Daily nausea/vomiting
Time frame: Postoperative day 3
Daily nausea/vomiting
Time frame: Postoperative day 4
Daily nausea/vomiting
Time frame: Postoperative day 5
Daily nausea/vomiting
Time frame: Postoperative day 6
Daily nausea/vomiting
Time frame: Postoperative day 7
Daily nausea/vomiting
Time frame: Postoperative day 8
Daily nausea/vomiting
Time frame: Postoperative day 9
Daily nausea/vomiting
Time frame: Postoperative day 10
Daily nausea/vomiting
Time frame: Postoperative day 11
Daily nausea/vomiting
Time frame: Postoperative day 12
Daily nausea/vomiting
Time frame: Postoperative day 13
Daily nausea/vomiting
Time frame: Postoperative day 14
Weight Change from Baseline
Time frame: Preoperative weight compared to postoperative weight at 2-3 weeks after surgery
Visit to emergency department after surgery
Time frame: Within 14 days after surgery
Post tonsillectomy hemorrhage
Time frame: Within 14 days after surgery
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 18656720Lee SW, Jeon SS, Lee JD, Lee JY, Kim SC, Koh YW. A comparison of postoperative pain and complications in tonsillectomy using BiClamp forceps and electrocautery tonsillectomy. Otolaryngol Head Neck Surg. 2008 Aug;139(2):228-34. doi: 10.1016/j.otohns.2008.04.004.
- Background: PubMed 16399189Parsons SP, Cordes SR, Comer B. Comparison of posttonsillectomy pain using the ultrasonic scalpel, coblator, and electrocautery. Otolaryngol Head Neck Surg. 2006 Jan;134(1):106-13. doi: 10.1016/j.otohns.2005.09.027.
- Background: PubMed 16885729Noordzij JP, Affleck BD. Coblation versus unipolar electrocautery tonsillectomy: a prospective, randomized, single-blind study in adult patients. Laryngoscope. 2006 Aug;116(8):1303-9. doi: 10.1097/01.mlg.0000225944.00189.e9.
- Background: PubMed 21812940Diakos EA, Gallos ID, El-Shunnar S, Clarke M, Kazi R, Mehanna H. Dexamethasone reduces pain, vomiting and overall complications following tonsillectomy in adults: a systematic review and meta-analysis of randomised controlled trials. Clin Otolaryngol. 2011 Dec;36(6):531-42. doi: 10.1111/j.1749-4486.2011.02373.x.
- Background: PubMed 11200596Thorneman G, Akervall J. Pain treatment after tonsillectomy: advantages of analgesics regularly given compared with analgesics on demand. Acta Otolaryngol. 2000 Oct;120(8):986-9. doi: 10.1080/00016480050218744.
- Background: PubMed 16211736Naesh O, Niles LA, Gilbert JG, Ammar MM, Phibbs PW, Phillips AM, Khrapov AV, Robert AJ, McClintock A. A randomized, placebo-controlled study of rofecoxib with paracetamol in early post-tonsillectomy pain in adults. Eur J Anaesthesiol. 2005 Oct;22(10):768-73. doi: 10.1017/s0265021505001274.
- Background: PubMed 15352967Hiller A, Silvanto M, Savolainen S, Tarkkila P. Propacetamol and diclofenac alone and in combination for analgesia after elective tonsillectomy. Acta Anaesthesiol Scand. 2004 Oct;48(9):1185-9. doi: 10.1111/j.1399-6576.2004.00473.x.
- Background: PubMed 11802045Salonen A, Kokki H, Nuutinen J. Recovery after tonsillectomy in adults: a three-week follow-up study. Laryngoscope. 2002 Jan;112(1):94-8. doi: 10.1097/00005537-200201000-00017.
- Background: PubMed 18033974Ashbach MN, Ostrower ST, Parikh SR. Tonsillectomy techniques and pain: a review of randomized controlled trials and call for standardization. ORL J Otorhinolaryngol Relat Spec. 2007;69(6):364-70. doi: 10.1159/000108369. Epub 2007 Nov 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Pate, M.D. principal investigator
University of Nebraska Medical Center Department of Otolaryngology - Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norco (Hydrocodone and Acetaminophen), Percocet (Oxycodone and Acetaminophen) and Dilaudid (hydromorphone) in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily pain level (time frame: Postoperative day 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02358850, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.