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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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

Other trials in United States

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):

  1. Norco (Hydrocodone and Acetaminophen)
  2. Percocet (Oxycodone and Acetaminophen)
  3. 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.

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 groups in NCT02358850
Study groupRoleWhat they receive
Tonsillectomy and NorcoActive comparatorThis 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 PercocetActive comparatorThis 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 + TylenolActive comparatorThis 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.

  1. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 1

  2. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 2

  3. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 3

  4. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 4

  5. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 5

  6. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 6

  7. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 7

  8. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 8

  9. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 9

  10. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 10

  11. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 11

  12. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 12

  13. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 13

  14. Daily pain level

    Daily pain level on scale from 0-10

    Measured: Postoperative day 14

Secondary outcomes (31)
  1. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 1

  2. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 2

  3. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 3

  4. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 4

  5. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 5

  6. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 6

  7. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 7

  8. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 8

  9. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 9

  10. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 10

  11. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 11

  12. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 12

  13. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 13

  14. Daily oral liquid intake

    Daily estimation of cups of liquids consumed

    Measured: Postoperative day 14

  15. Daily nausea/vomiting

    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

    Measured: Postoperative day 1

  16. Daily nausea/vomiting

    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

    Measured: Postoperative day 2

  17. Daily nausea/vomiting

    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

    Measured: Postoperative day 3

  18. Daily nausea/vomiting

    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

    Measured: Postoperative day 4

  19. Daily nausea/vomiting

    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

    Measured: Postoperative day 5

  20. Daily nausea/vomiting

    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

    Measured: Postoperative day 6

  21. Daily nausea/vomiting

    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

    Measured: Postoperative day 7

  22. Daily nausea/vomiting

    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

    Measured: Postoperative day 8

  23. Daily nausea/vomiting

    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

    Measured: Postoperative day 9

  24. Daily nausea/vomiting

    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

    Measured: Postoperative day 10

  25. Daily nausea/vomiting

    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

    Measured: Postoperative day 11

  26. Daily nausea/vomiting

    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

    Measured: Postoperative day 12

  27. Daily nausea/vomiting

    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

    Measured: Postoperative day 13

  28. Daily nausea/vomiting

    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

    Measured: Postoperative day 14

  29. 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

  30. 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

  31. 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.

  1. First posted9 Feb 2015 (estimated)
  2. Study startJan 2016
  3. Primary completion24 Jan 2019
  4. Study completion24 Jan 2019

Why it stopped: low enrollment

Resources

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)
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 18656720
  • Parsons 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 16399189
  • Noordzij 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 16885729
  • Diakos 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 21812940
  • Thorneman 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 11200596
  • Naesh 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 16211736
  • Hiller 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 15352967
  • Salonen 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 11802045
  • Ashbach 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

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.

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