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Trial record 74 of 145 for:    Hydrocodone

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

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Postoperative Nausea and Vomiting Postoperative Hemorrhage Body Weight Changes Drug: Norco (Hydrocodone and Acetaminophen) Drug: Percocet (Oxycodone and Acetaminophen) Drug: Dilaudid (hydromorphone) Drug: Tylenol (Acetaminophen) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-tonsillectomy Pain Control in Adults: a Randomized Prospective Study
Study Start Date : January 2016
Estimated Primary Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tonsillectomy and Norco
This represents patients who will be randomized (1:3 chance) to postoperative pain control with Norco (Hydrocodone and Acetaminophen)
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

Active Comparator: Tonsillectomy and Percocet
This represents patients who will be randomized (1:3 chance) to postoperative pain control with Percocet (Oxycodone and Acetaminophen)
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

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)
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




Primary Outcome Measures :
  1. Daily pain level [ Time Frame: Postoperative day 1 ]
    Daily pain level on scale from 0-10

  2. Daily pain level [ Time Frame: Postoperative day 2 ]
    Daily pain level on scale from 0-10

  3. Daily pain level [ Time Frame: Postoperative day 3 ]
    Daily pain level on scale from 0-10

  4. Daily pain level [ Time Frame: Postoperative day 4 ]
    Daily pain level on scale from 0-10

  5. Daily pain level [ Time Frame: Postoperative day 5 ]
    Daily pain level on scale from 0-10

  6. Daily pain level [ Time Frame: Postoperative day 6 ]
    Daily pain level on scale from 0-10

  7. Daily pain level [ Time Frame: Postoperative day 7 ]
    Daily pain level on scale from 0-10

  8. Daily pain level [ Time Frame: Postoperative day 8 ]
    Daily pain level on scale from 0-10

  9. Daily pain level [ Time Frame: Postoperative day 9 ]
    Daily pain level on scale from 0-10

  10. Daily pain level [ Time Frame: Postoperative day 10 ]
    Daily pain level on scale from 0-10

  11. Daily pain level [ Time Frame: Postoperative day 11 ]
    Daily pain level on scale from 0-10

  12. Daily pain level [ Time Frame: Postoperative day 12 ]
    Daily pain level on scale from 0-10

  13. Daily pain level [ Time Frame: Postoperative day 13 ]
    Daily pain level on scale from 0-10

  14. Daily pain level [ Time Frame: Postoperative day 14 ]
    Daily pain level on scale from 0-10


Secondary Outcome Measures :
  1. Daily oral liquid intake [ Time Frame: Postoperative day 1 ]
    Daily estimation of cups of liquids consumed

  2. Daily oral liquid intake [ Time Frame: Postoperative day 2 ]
    Daily estimation of cups of liquids consumed

  3. Daily oral liquid intake [ Time Frame: Postoperative day 3 ]
    Daily estimation of cups of liquids consumed

  4. Daily oral liquid intake [ Time Frame: Postoperative day 4 ]
    Daily estimation of cups of liquids consumed

  5. Daily oral liquid intake [ Time Frame: Postoperative day 5 ]
    Daily estimation of cups of liquids consumed

  6. Daily oral liquid intake [ Time Frame: Postoperative day 6 ]
    Daily estimation of cups of liquids consumed

  7. Daily oral liquid intake [ Time Frame: Postoperative day 7 ]
    Daily estimation of cups of liquids consumed

  8. Daily oral liquid intake [ Time Frame: Postoperative day 8 ]
    Daily estimation of cups of liquids consumed

  9. Daily oral liquid intake [ Time Frame: Postoperative day 9 ]
    Daily estimation of cups of liquids consumed

  10. Daily oral liquid intake [ Time Frame: Postoperative day 10 ]
    Daily estimation of cups of liquids consumed

  11. Daily oral liquid intake [ Time Frame: Postoperative day 11 ]
    Daily estimation of cups of liquids consumed

  12. Daily oral liquid intake [ Time Frame: Postoperative day 12 ]
    Daily estimation of cups of liquids consumed

  13. Daily oral liquid intake [ Time Frame: Postoperative day 13 ]
    Daily estimation of cups of liquids consumed

  14. Daily oral liquid intake [ Time Frame: Postoperative day 14 ]
    Daily estimation of cups of liquids consumed

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. Post tonsillectomy hemorrhage [ Time Frame: Within 14 days after surgery ]
    If patient had a post tonsillectomy hemorrhage and if any treatment was needed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358850


Contacts
Contact: Mark A Miller, M.D. 402-559-7005 mark.miller@unmc.edu

Locations
United States, Nebraska
University Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Mark Miller, MD    402-559-7005    mark.miller@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Samuel Pate, M.D. University of Nebraska Medical Center Department of Otolaryngology - Head and Neck Surgery

Publications:

Responsible Party: Samuel Pate MD, M.D., University of Nebraska
ClinicalTrials.gov Identifier: NCT02358850     History of Changes
Other Study ID Numbers: 658-14
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by Samuel Pate MD, University of Nebraska:
Tonsillectomy
Adenoidectomy

Additional relevant MeSH terms:
Acetaminophen, hydrocodone drug combination
Hydrocodone
Hemorrhage
Vomiting
Body Weight
Pain, Postoperative
Postoperative Nausea and Vomiting
Body Weight Changes
Postoperative Hemorrhage
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Nausea
Acetaminophen
Oxycodone
Hydromorphone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents