Pain Medications Following Thyroidectomy and Parathyroidectomy
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ClinicalTrials.gov Identifier: NCT03640247 |
Recruitment Status :
Completed
First Posted : August 21, 2018
Last Update Posted : December 26, 2019
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Condition or disease | Intervention/treatment | Phase |
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Thyroid Disease Parathyroid Diseases | Drug: Non-narcotic group regimen Drug: Narcotic group regimen | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 126 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 |
Actual Primary Completion Date : | December 1, 2019 |
Actual Study Completion Date : | December 1, 2019 |
Arm | Intervention/treatment |
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Narcotic group regimen
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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:
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Active Comparator: Non-narcotic group regimen
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Drug: Non-narcotic group regimen
Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen
Other Names:
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- 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).
- 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)
- 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
- 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 |
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

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
United States, Ohio | |
MetroHealth Medical Center | |
Cleveland, Ohio, United States, 44109 |
Principal Investigator: | Christopher R McHenry, MD | MetroHealth Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Christopher McHenry, MD, Director, Division of General Surgery, MetroHealth Medical Center |
ClinicalTrials.gov Identifier: | NCT03640247 |
Other Study ID Numbers: |
IRB18-00412 |
First Posted: | August 21, 2018 Key Record Dates |
Last Update Posted: | December 26, 2019 |
Last Verified: | December 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Thyroidectomy Parathryoidectomy |
Thyroid Diseases Parathyroid Diseases Endocrine System Diseases Acetaminophen Ibuprofen Oxycodone Tramadol Hydrocodone Narcotics Analgesics, Non-Narcotic Analgesics 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 |