NCT03469310

Minimizing Narcotic Analgesics After Endocrine Surgery

Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Minerva A Romero Arenas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

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.

Conditions

• Thyroid Cancer
• Thyroid Nodule
• Thyroid Neoplasms
• Thyroid Goitre
• Thyroid Diseases
• Parathyroid Diseases
• Parathyroid Adenoma
• Parathyroid Hyperplasia

Interventions

Type	Name	Description
DRUG	Acetaminophen 500Mg Cap	non-narcotic medication first with narcotic as second choice
DRUG	Tylenol #3 Oral Tablet	Narcotic medication first
DRUG	Tramadol	non-narcotic medication first with narcotic as second choice

Timeline

• Start date: 2018-03-09
• Primary completion: 2019-12-21
• Completion: 2020-10-02
• First posted: 2018-03-19
• Last updated: 2021-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study