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Pain Medications Following Thyroidectomy and Parathyroidectomy

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ClinicalTrials.gov Identifier: NCT03640247
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher McHenry, MetroHealth Medical Center

Brief Summary:
The purpose of this study is to evaluate the use of a non-narcotic, postoperative pain management regimen on patients undergoing thyroidectomy and parathyroidectomy.

Condition or disease Intervention/treatment Phase
Thyroid Disease Parathyroid Diseases Drug: Non-narcotic group regimen Drug: Narcotic group regimen Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: All party or parties involved have knowledge of the interventions assigned to individual participants
Primary Purpose: Treatment
Official Title: Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Arm Intervention/treatment
Narcotic group regimen
  • Tylenol tablet 1000 mg by mouth every 8 hours alternating with
  • Ibuprofen tablet 800 mg by mouth every 8 hours
  • Oxycodone 5 mg by mouth every 6 hours as needed for pain, #10 tablet or if needed based on patient allergies, hydrocodone 5 mg/tramadol 50 mg.
Drug: Narcotic group regimen
Narcotic Group: Alternating acetaminophen and ibuprofen, with a prescription of 10 tablets oxycodone (or if needed based on patient allergies, hydrocodone 5 mg/tramadol 50 mg) for break through pain.
Other Names:
  • Ibuprofen 800mg every 8 hours
  • Oxycodone 5mg every 6 hours prn for pain.
  • Hydrocodone 5 mg every 6 hours prn for pain
  • Tramadol 50 mg every 6 hours prn for pain
  • Acetaminophen 500Mg Tab x2 every 8 hours

Active Comparator: Non-narcotic group regimen
  • Tylenol tablet 1000 mg by mouth every 8 hours alternating with
  • Ibuprofen tablet 800 mg by mouth every 8 hours
Drug: Non-narcotic group regimen
Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen
Other Names:
  • Ibuprofen 800mg every 8 hours
  • Acetaminophen 500Mg Tab x2 every 8 hours




Primary Outcome Measures :
  1. Overall mean pain as assessed by 10 point visual analogue scale from the 6 post operative day time points. [ Time Frame: Overall mean pain score from 6 time points (Post operative days 0,1,2,3,4,5) ]
    10 point visual analogue scale- (0- no pain, 1-3 mild, 4-6 moderate pain, 7-10 severe pain).


Secondary Outcome Measures :
  1. Patient satisfaction with the pain medication regimen as assessed by 3-point likert scale from the 6 post operative day time points. [ Time Frame: Mean patient satisfaction score from 6 time points (Post operative days 0,1,2,3,4,5) ]
    3 point likert scale (1- easy to manage, 2- manageable but not easy 3- difficult to manage)

  2. Total dose of oral narcotics converted into oral morphine equivalents (see below) that were taken by participants post-operatively [ Time Frame: Mean oral morphine equivalents from 6 time points (Post operative days 0,1,2,3,4,5) ]

    Oral morphine equivalents(OMEQ):

    Hydrocodone 5mg =1 OMEQ

    Oxycodone 5mg = 1.5 OMEQ

    Hydromorphone 1mg = 4 OMEQ

    Codeine 5mg = 0.15 OMEQ

    Tramadol 5mg = 0.20 OMEQ


  3. Mean number of office calls/contacts from the 6 post operative day time points. [ Time Frame: Mean number of office calls/contacts from 6 time points (Post operative days 0,1,2,3,4,5) ]
    Mean number of office calls/contacts from participants from post operative day 0, 1,2,3,4,5.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or greater
  • Undergoing total thyroidectomy, partial thyroidectomy or parathyroidectomy at MetroHealth Medical Center

Exclusion Criteria:

  • Patients taking narcotics prior to surgery
  • Patients who are unable or unwilling to follow study protocol requirements

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): NCT03640247


Contacts
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Contact: Angelina Mijailovic, MSPAS (216)-778-4226 AMIJAILOVIC1@METROHEALTH.ORG

Locations
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United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Angelina Mijailovic, MPAS, PA-C    440-778-4226    amijailovic@metrohealth.org   
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
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Principal Investigator: Christopher R McHenry, MD MetroHealth Medical Center

Publications:
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Responsible Party: Christopher McHenry, MD, Director, Division of General Surgery, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT03640247     History of Changes
Other Study ID Numbers: IRB18-00412
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Christopher McHenry, MetroHealth Medical Center:
Thyroidectomy
Parathryoidectomy
Additional relevant MeSH terms:
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Acetaminophen
Thyroid Diseases
Parathyroid Diseases
Endocrine System Diseases
Ibuprofen
Oxycodone
Tramadol
Hydrocodone
Narcotics
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents