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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

Tracking Information
First Submitted Date  ICMJE March 7, 2018
First Posted Date  ICMJE March 19, 2018
Last Update Posted Date February 25, 2019
Actual Study Start Date  ICMJE March 9, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03469310 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minimizing Narcotic Analgesics After Endocrine Surgery
Official Title  ICMJE Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Thyroid Cancer
  • Thyroid Nodule
  • Thyroid Neoplasms
  • Thyroid Goitre
  • Thyroid Diseases
  • Parathyroid Diseases
  • Parathyroid Adenoma
  • Parathyroid Hyperplasia
Intervention  ICMJE
  • Drug: Acetaminophen 500Mg Cap
    non-narcotic medication first with narcotic as second choice
    Other Name: Tylenol
  • Drug: Tylenol #3 Oral Tablet
    Narcotic medication first
    Other Name: codeine-acetaminophen
  • Drug: Tramadol
    non-narcotic medication first with narcotic as second choice
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Acetaminophen 500Mg Cap
    • Drug: Tramadol
  • Active Comparator: Codeine Acetaminophen
    Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain
    Intervention: Drug: Tylenol #3 Oral Tablet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2018)
126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03469310
Other Study ID Numbers  ICMJE 1177315
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified information only will be made available to interested researchers.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Minerva Romero Arenas, MD, MPH, Doctors Hospital at Renaissance
Study Sponsor  ICMJE Minerva Romero Arenas, MD, MPH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Doctors Hospital at Renaissance
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP