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.
Exclusion Criteria:
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, Icf
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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