Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Experimental | 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 |
|
| Codeine Acetaminophen | Active Comparator | Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen 500Mg Cap | Drug | non-narcotic medication first with narcotic as second choice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Patient will report pain score up to two weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Patient will report medication requirements up to two weeks after surgery |
| Is there a difference in the medication requirement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Minerva A Romero Arenas, MD, MPH | GME General Surgery | Principal Investigator |
| Samuel K Snyder, MD | GME General Surgery | Principal Investigator |
| Henry A Reinhart, MD | GME General Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GME General Surgery Clinic | Edinburg | Texas | 78539 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28033313 | Background | 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. | |
| 27429023 | Background | 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. |
Not provided
Not provided
De-identified information only will be made available to interested researchers.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D016606 | Thyroid Nodule |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D010279 | Parathyroid Diseases |
| D010282 | Parathyroid Neoplasms |
| D009293 | Opioid-Related Disorders |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D002214 | Capsules |
| C526278 | acetaminophen, codeine drug combination |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
option 1: Tylenol (also known as acetaminophen) with tramadol if needed, or option 2: Tylenol #3 as needed
Not provided
Not provided
Not provided
Not provided
| Tylenol #3 Oral Tablet | Drug | Narcotic medication first |
|
|
| Tramadol | Drug | non-narcotic medication first with narcotic as second choice |
|
The type and quantity of pain medications used after surgery will be counted and assessed for difference between the study arms |
| 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 | Patient will report medication requirements up to two weeks after surgery |
| 27163960 | Background | 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. |
| 26987082 | Background | 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. |
| 28973092 | Background | 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. |
| 28973361 | Background | 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. |
| D004700 |
| Endocrine System Diseases |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D008055 | Lipids |