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Trial record 13 of 74 for:    Codeine AND Acetaminophen

Minimizing Narcotic Analgesics After Endocrine Surgery

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ClinicalTrials.gov Identifier: NCT03469310
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Minerva Romero Arenas, MD, MPH, Doctors Hospital at Renaissance

Brief 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.


Condition or disease Intervention/treatment Phase
Thyroid Cancer Thyroid Nodule Thyroid Neoplasms Thyroid Goitre Thyroid Diseases Parathyroid Diseases Parathyroid Adenoma Parathyroid Hyperplasia Drug: Acetaminophen 500Mg Cap Drug: Tylenol #3 Oral Tablet Drug: Tramadol Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: option 1: Tylenol (also known as acetaminophen) with tramadol if needed, or option 2: Tylenol #3 as needed
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery
Actual Study Start Date : March 9, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acetaminophen
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
non-narcotic medication first with narcotic as second choice
Other Name: Tylenol

Drug: Tramadol
non-narcotic medication first with narcotic as second choice

Active Comparator: Codeine Acetaminophen
Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain
Drug: Tylenol #3 Oral Tablet
Narcotic medication first
Other Name: codeine-acetaminophen




Primary Outcome Measures :
  1. 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 ]
    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


Secondary Outcome Measures :
  1. Is there a difference in the duration of postoperative pain requiring medication [ Time Frame: Patient will report medication requirements up to two weeks after surgery ]
    The number of days after surgery that participants required pain medications will be counted and assessed for difference between the study arms

  2. Is there a difference in the medication requirement [ Time Frame: Patient will report medication requirements up to two weeks after surgery ]
    The type and quantity of pain medications used after surgery will be counted and assessed for difference between the study arms

  3. Staged regimen cross over to narcotic [ Time Frame: Patient will report medication requirements up to two weeks after surgery ]
    The type and quantity of pain medications used after surgery will be counted and number of patients requiring cross over will be assessed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients 18 years of age or older,
  2. Who are undergoing thyroid or parathyroid surgery at DHR by an Endocrine Surgery faculty member,
  3. Provide informed consent to participate in the study in English or Spanish,
  4. Patients will be included if they are discharged the same day or on postoperative day 1,
  5. Patients who undergo central lymphadenectomy will be included,
  6. 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.
  7. 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.

Exclusion Criteria:

  1. 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;
  2. Patients allergic to any of the study drugs will be ineligible;
  3. 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.
  4. Patients with a formal diagnosis of hepatic failure will be ineligible
  5. Patients with any diagnosis of chronic pain requiring treatment with ongoing narcotic regimen will be ineligible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469310


Contacts
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Contact: Minerva A Romero Arenas, MD, MPH (956)362-3501 minerva.romeroarenas@utrgv.edu
Contact: Amber E Deane, PhD (956) 362-2379 a.deane@dhr-rgv.com

Locations
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United States, Texas
GME General Surgery Clinic Recruiting
Edinburg, Texas, United States, 78539
Contact: Minerva A Romero Arenas, MD, MPH    956-362-3501    minerva.romeroarenas@utrgv.edu   
Contact: Amber Deane, PhD    (956) 362.2379    a.deane@dhr-rgv.com   
Sponsors and Collaborators
Minerva Romero Arenas, MD, MPH
Investigators
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Principal Investigator: 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

Publications:
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Responsible Party: Minerva Romero Arenas, MD, MPH, Principal Investigator, Doctors Hospital at Renaissance
ClinicalTrials.gov Identifier: NCT03469310     History of Changes
Other Study ID Numbers: 1177315
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified information only will be made available to interested researchers.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Minerva Romero Arenas, MD, MPH, Doctors Hospital at Renaissance:
endocrine surgery
opioid addiction
pain management
analgesia
Additional relevant MeSH terms:
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Acetaminophen
Codeine
Thyroid Neoplasms
Adenoma
Thyroid Nodule
Parathyroid Neoplasms
Thyroid Diseases
Parathyroid Diseases
Hyperplasia
Endocrine System Diseases
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Tramadol
Narcotics
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents