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Thyroid CancerPhase 4NCT03469310

Minimizing Narcotic Analgesics After Endocrine Surgery

A Phase 4 study testing Acetaminophen 500Mg Cap, Tylenol #3 Oral Tablet and Tramadol in people with Thyroid Cancer and Thyroid Nodule, run by Minerva A Romero Arenas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research is being done to better understand and test if the investigators can minimize narcotic medication for controlling pain after thyroid or parathyroid surgery. This research will be performed at Doctors Hospital At Renaissance in the investigators clinic and the perioperative area. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer, Thyroid Nodule, Thyroid Neoplasms
What is being tested?
Acetaminophen 500Mg Cap, Tylenol #3 Oral Tablet and Tramadol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteUnited States
Study dates
9 Mar 2018to 2 Oct 2020
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients 18 years of age or older,
  • Who are undergoing thyroid or parathyroid surgery at DHR by an Endocrine Surgery faculty member,
  • Provide informed consent to participate in the study in English or Spanish,
  • Patients will be included if they are discharged the same day or on postoperative day 1,
  • Patients who undergo central lymphadenectomy will be included,
  • Patients who undergo two operations within a 2-week period (for example a thyroid lobectomy followed by subsequent completion thyroidectomy) will only have the postoperative narcotic requirements following the initial operation included for the study analysis.
  • Patients who have a complication, such as seroma or hematoma, requiring return to the operating room within 48 hours will be included in the study for the initial operation only.

Who cannot join

  • Patients who undergo lateral neck lymph node dissection will be excluded from the study due to the extent of the operation requiring a different analgesic regimen;
  • Patients allergic to any of the study drugs will be ineligible;
  • Patients who undergo two operations within a 2-week period (for example a thyroid lobectomy followed by subsequent completion thyroidectomy) will only have the initial operation included for the study analysis.
  • Patients with a formal diagnosis of hepatic failure will be ineligible
  • Patients with any diagnosis of chronic pain requiring treatment with ongoing narcotic regimen will be ineligible

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GME General Surgery Clinic

    Edinburg, Texas, 78539

Other trials in United States

About this study

Official title: Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery

This research is being done to better understand and test if the investigators can minimize narcotic medication for controlling pain after thyroid or parathyroid surgery. This research will be performed at Doctors Hospital At Renaissance in the investigators clinic and the perioperative area.

Participants will be randomly chosen to receive one of two options for pain management that the investigators are already using in the care of patients after surgery. One option includes a narcotic medication and one option includes a non-narcotic and a narcotic as needed.

Participants will be asked to complete a form about the level of pain and how much pain medication was needed after surgery in the hospital and while at home. Participants will not have to do any additional visits to participate in this study. The investigators will obtain the research materials at the same time as the usual care visits around the participants' surgery.

Read the detailed description

A study team member will give the participant a copy of the informed consent form to read. Participants will have a chance to ask questions about the study before agreeing to participate. If participants agree, they will be randomly chosen to receive one of two options for pain management that the investigators are already using in the care of patients (option 1: Tylenol (also known as acetaminophen) with tramadol if needed, or option 2: Tylenol #3 as needed) after surgery.

Participants will be asked to complete a form about the level of pain and how much pain medication was needed after surgery in the hospital and while at home. Participants will come to the GME General Surgery Center approximately one week after surgery for a post-operative visit so that the investigators can see how much pain medication was used and how much pain the participant had in the first few days after surgery.

Participants will not have to do any additional visits to participate in this study. The investigators will obtain the research materials at the same time as the usual care visits around the participants' surgery. It should take approximately 2 minutes each day to complete.

Being tested
Acetaminophen 500Mg Cap, Tylenol #3 Oral Tablet, Tramadol
Keywords
endocrine surgery, opioid addiction, pain management, analgesia
Medical subject headings
Thyroid Neoplasms, Thyroid Nodule, Goiter, Thyroid Diseases, Parathyroid Diseases, Parathyroid Neoplasms, Opioid-Related Disorders, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acetaminophen 500Mg CapDrug

    Also called Tylenol

    non-narcotic medication first with narcotic as second choice

  • Tylenol #3 Oral TabletDrug

    Also called codeine-acetaminophen

    Narcotic medication first

  • TramadolDrug

    non-narcotic medication first with narcotic as second choice

Study groups in NCT03469310
Study groupRoleWhat they receive
AcetaminophenExperimentalTylenol (also known as acetaminophen) 1000mg every 6 hours for 3 days and tramadol 50 mg every 6 hours as needed for moderate to severe pain
Receives: Drug: Acetaminophen 500Mg Cap; Drug: Tramadol
Codeine AcetaminophenActive comparatorTylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain
Receives: Drug: Tylenol #3 Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Staged narcotic analgesic regimen is non-inferior to narcotics in controlling pain

    Patient pain scores will be logged using Wong-Baker FACES pain rating scale (range 0-10) and scores will be assessed for differences between the study arms

    Measured: Patient will report pain score up to two weeks after surgery

Secondary outcomes (3)

  1. Is there a difference in the duration of postoperative pain requiring medication

    The number of days after surgery that participants required pain medications will be counted and assessed for difference between the study arms

    Measured: Patient will report medication requirements up to two weeks after surgery

  2. Is there a difference in the medication requirement

    The type and quantity of pain medications used after surgery will be counted and assessed for difference between the study arms

    Measured: Patient will report medication requirements up to two weeks after surgery

  3. Staged regimen cross over to narcotic

    The type and quantity of pain medications used after surgery will be counted and number of patients requiring cross over will be assessed

    Measured: Patient will report medication requirements up to two weeks 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 posted19 Mar 2018
  2. Study start9 Mar 2018
  3. Primary completion21 Dec 2019
  4. Study completion2 Oct 2020

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
option 1: Tylenol (also known as acetaminophen) with tramadol if needed, or option 2: Tylenol #3 as needed
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03469310
Sponsor's protocol ID
1177315
Status last verified
May 2021
First submitted
7 Mar 2018
Last updated
11 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified information only will be made available to interested researchers.

Publications

  • Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.

    PubMed 28033313

  • Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.

    PubMed 27429023

  • Jiang X, Orton M, Feng R, Hossain E, Malhotra NR, Zager EL, Liu R. Chronic Opioid Usage in Surgical Patients in a Large Academic Center. Ann Surg. 2017 Apr;265(4):722-727. doi: 10.1097/SLA.0000000000001780.

    PubMed 27163960

  • Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1.

    PubMed 26987082

  • Scully RE, Schoenfeld AJ, Jiang W, Lipsitz S, Chaudhary MA, Learn PA, Koehlmoos T, Haider AH, Nguyen LL. Defining Optimal Length of Opioid Pain Medication Prescription After Common Surgical Procedures. JAMA Surg. 2018 Jan 1;153(1):37-43. doi: 10.1001/jamasurg.2017.3132.

    PubMed 28973092

  • Rogers SO Jr. Addressing Variability in Opioid Prescribing. JAMA Surg. 2018 Jan 1;153(1):43. doi: 10.1001/jamasurg.2017.3166. No abstract available.

    PubMed 28973361

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Acetaminophen 500Mg Cap, Tylenol #3 Oral Tablet and Tramadol in people with Thyroid Cancer and Thyroid Nodule, run by Minerva A Romero Arenas 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 11 May 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Staged narcotic analgesic regimen is non-inferior to narcotics in controlling pain (time frame: Patient will report pain score up to two weeks after surgery). 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 NCT03469310, which also lists 6 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 11 May 2021; AzTrials last refreshed its copy on 26 Oct 2026.

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