A Phase 4 interventional study of Acetaminophen 500Mg Cap and Tylenol #3 Oral Tablet in Thyroid Cancer, Thyroid Nodule and Thyroid Neoplasms, sponsored by Minerva A Romero Arenas. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-11.
Sponsored by Minerva A Romero Arenas · Phase 4, Interventional, and Supportive care
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.
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.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's enrollment of 126 is above the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →This is the only study on the registry with Minerva A Romero Arenas as lead sponsor.
Compared within Thyroid Nodule, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Thyroid Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tylenol (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
Drug: Acetaminophen 500Mg Cap · Drug: Tramadol
Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain
Drug: Tylenol #3 Oral Tablet
non-narcotic medication first with narcotic as second choice
Also known as: Tylenol
Narcotic medication first
Also known as: codeine-acetaminophen
non-narcotic medication first with narcotic as second choice
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
Time frame: Patient will report pain score up to two weeks after surgery
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
Time frame: Patient will report medication requirements up to two weeks after surgery
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
Time frame: Patient will report medication requirements up to two weeks after surgery
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
Time frame: Patient will report medication requirements up to two weeks after surgery
Plan to share: Yes — De-identified information only will be made available to interested researchers.
Supporting information: Study protocol, Informed consent form
Ran from Mar 2018 to primary completion in Dec 2019, 21 months.
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Acetaminophen · Tramadol