Pain Medications Following Thyroidectomy and Parathyroidectomy
Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy
1 other identifier
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedStudy Start
First participant enrolled
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedDecember 26, 2019
December 1, 2019
1 year
July 24, 2018
December 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall mean pain as assessed by 10 point visual analogue scale from the 6 post operative day time points.
10 point visual analogue scale- (0- no pain, 1-3 mild, 4-6 moderate pain, 7-10 severe pain).
Overall mean pain score from 6 time points (Post operative days 0,1,2,3,4,5)
Secondary Outcomes (3)
Patient satisfaction with the pain medication regimen as assessed by 3-point likert scale from the 6 post operative day time points.
Mean patient satisfaction score from 6 time points (Post operative days 0,1,2,3,4,5)
Total dose of oral narcotics converted into oral morphine equivalents (see below) that were taken by participants post-operatively
Mean oral morphine equivalents from 6 time points (Post operative days 0,1,2,3,4,5)
Mean number of office calls/contacts from the 6 post operative day time points.
Mean number of office calls/contacts from 6 time points (Post operative days 0,1,2,3,4,5)
Study Arms (2)
Narcotic group regimen
OTHER* 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.
Non-narcotic group regimen
ACTIVE COMPARATOR* Tylenol tablet 1000 mg by mouth every 8 hours alternating with * Ibuprofen tablet 800 mg by mouth every 8 hours
Interventions
Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen
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.
Eligibility Criteria
You may qualify if:
- Age 18 years or greater
- Undergoing total thyroidectomy, partial thyroidectomy or parathyroidectomy at MetroHealth Medical Center
You may not qualify if:
- Patients taking narcotics prior to surgery
- Patients who are unable or unwilling to follow study protocol requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Related Publications (6)
Fujii MH, Hodges AC, Russell RL, Roensch K, Beynnon B, Ahern TP, Holoch P, Moore JS, Ames SE, MacLean CD. Post-Discharge Opioid Prescribing and Use after Common Surgical Procedure. J Am Coll Surg. 2018 Jun;226(6):1004-1012. doi: 10.1016/j.jamcollsurg.2018.01.058. Epub 2018 Feb 28.
PMID: 29499361BACKGROUNDHill MV, Stucke RS, Billmeier SE, Kelly JL, Barth RJ Jr. Guideline for Discharge Opioid Prescriptions after Inpatient General Surgical Procedures. J Am Coll Surg. 2018 Jun;226(6):996-1003. doi: 10.1016/j.jamcollsurg.2017.10.012. Epub 2017 Nov 30.
PMID: 29198638BACKGROUNDLong SM, Lumley CJ, Zeymo A, Davidson BJ. Prescription and Usage Pattern of Opioids after Thyroid and Parathyroid Surgery. Otolaryngol Head Neck Surg. 2019 Mar;160(3):388-393. doi: 10.1177/0194599818779776. Epub 2018 May 29.
PMID: 29807482BACKGROUNDLou I, Chennell TB, Schaefer SC, Chen H, Sippel RS, Balentine C, Schneider DF, Moalem J. Optimizing Outpatient Pain Management After Thyroid and Parathyroid Surgery: A Two-Institution Experience. Ann Surg Oncol. 2017 Jul;24(7):1951-1957. doi: 10.1245/s10434-017-5781-y. Epub 2017 Feb 3.
PMID: 28160140BACKGROUNDTan WH, Yu J, Feaman S, McAllister JM, Kahan LG, Quasebarth MA, Blatnik JA, Eagon JC, Awad MM, Brunt LM. Opioid Medication Use in the Surgical Patient: An Assessment of Prescribing Patterns and Use. J Am Coll Surg. 2018 Aug;227(2):203-211. doi: 10.1016/j.jamcollsurg.2018.04.032. Epub 2018 May 7.
PMID: 29746919BACKGROUNDBrady JT, Dreimiller A, Miller-Spalding S, Gesang T, Sehgal AR, McHenry CR. Are narcotic pain medications necessary after discharge following thyroidectomy and parathyroidectomy? Surgery. 2021 Jan;169(1):202-208. doi: 10.1016/j.surg.2020.03.027. Epub 2020 May 14.
PMID: 32416981DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher R McHenry, MD
MetroHealth Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- All party or parties involved have knowledge of the interventions assigned to individual participants
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Director, Division of General Surgery
Study Record Dates
First Submitted
July 24, 2018
First Posted
August 21, 2018
Study Start
November 15, 2018
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
December 26, 2019
Record last verified: 2019-12