Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Intravenous Acetaminophen in Patients Undergoing Thoracoscopic Surgery (IVTylenol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051932
Recruitment Status : Withdrawn (Not funded)
First Posted : February 14, 2017
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
This is a single-center, randomized, double-blind, placebo-controlled trial. A total of 100 patients, 50 per treatment arm, undergoing minimally invasive thoracic surgery will be randomized 1:1 across 2 treatment arms: Ofiramev® (acetaminophen) injection 1,000 mg (100 mL) plus patient-controlled analgesia (PCA) and 100 mL placebo plus PCA.

Condition or disease Intervention/treatment Phase
Post-thoracotomy Pain Syndrome Drug: Ofiramev® (IV Acetaminophen) Drug: Placebo IV administration Not Applicable

Detailed Description:

This is a single-center, randomized, double-blind, placebo-controlled trial. A total of 100 patients, 50 patient per treatment arm, undergoing minimally invasive thoracic surgery will be randomized 1:1 across 2 treatment arms: Ofiramev® (acetaminophen) injection 1,000 mg (100 mL) plus patient-controlled analgesia (PCA) and 100 mL placebo plus PCA. All patients will be enrolled from a single site.50 patient will be enrolled in each arm (placebo/ acetamophin). Each subject will be administered a single dose of study drug or placebo infused over 15-minutes, four times, six hours apart. The duration of subject participation will be ten weeks. Total duration of the study is expected to be 52 weeks. The primary endpoints of the study will be the amount of postoperative narcotic used, patient assessment of pain as measured by a validated pain survey, and length of stay in the hospital.

For postoperative pain assessment, the Numeric Rating Scale (NRS) will be used (NRS: 0-10; 0: no pain, 10: worst pain imaginable). Pain will be evaluated at 2-hour intervals in the post-anesthesia care unit followed by 4-hour intervals once the patient is transferred to the floor. Nurses who are blinded to the analgesic method will evaluate pain levels. Hospital length of stay will be measured from date of admission to date of discharge.

The study drug, Ofiramev® (acetaminophen) injection is a non-salicylate antipyretic and non-opioid analgesic agent. The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions. The study drug is a clear, colorless formulation of acetaminophen intended for intravenous infusion and is packaged in glass vials containing 100 mL of 1000 mg acetaminophen (10 mg/mL). The investigational pharmacy will transfer the study drug to a 100 mL bag. The placebo solution will consist of 100 mL normal saline in an identical 100 mL bag with identical labeling. Prior to the induction of anesthesia subjects will receive a single dose of Ofiramev® or placebo by IV infusion over 15 minutes. Following the first dose, each subsequent dose will be given every 6 hours for a total of 4 doses. Regardless of treatment arm, study drug and placebo will be dispensed in the same manner.

Investigational drugs are stored in the investigational drug service storeroom and/or pharmacy satellite depending on the nature of the drug study. All study drug inventory is labeled with IRB identification and stored separately from other commercial drug products under appropriate security and stability conditions. OFIRMEV should be stored at 20°C to 25°C (68°F to 77°F) and should be used within 6 hours after opening.

An accurate and current accounting of the dispensing and return of study drug for each subject will be maintained on an ongoing basis by a member of the study site staff. The number of study drug dispensed and returned by the subject will be recorded on the Investigational Drug Accountability Record. The study monitor will verify these documents throughout the course of the study.

Patients can voluntarily withdraw from the trial for any reason at any time. Subjects will be withdrawn from the study in the event of unplanned conversion to open thoracic surgery or administration of neuraxial opioids. If a subject is withdrawn from treatment due to an adverse event, the subject will be followed and treated by the Investigator until the abnormal parameter or symptom has resolved or stabilized.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Intravenous Acetaminophen in Patients Undergoing Thoracoscopic Surgery
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ofiramev®( IV Acetaminophen)
Patients randomized to the treatment arm will receive 1 g (100 mL) intravenous acetaminophen infused over 15-minutes every 6 hours for 4 doses total.
Drug: Ofiramev® (IV Acetaminophen)
Post -op pain medication
Other Name: IV Tylenol

Placebo Comparator: Placebo IV administration
Patients randomized to the placebo arm will receive 100 mL of normal saline infused over 15 minutes every 6 hours for 4 doses total
Drug: Placebo IV administration
Post -op pain
Other Name: Normal Saline




Primary Outcome Measures :
  1. The amount of postoperative narcotic used. [ Time Frame: Within 7 days of surgery ]
    the amount of postoperative narcotic used, after surgery.


Secondary Outcome Measures :
  1. The amount of postoperative pain. [ Time Frame: An average of 4 days ]
    The amount of postoperative patient assessment of pain as measured by a validated pain survey (NRS)

  2. length of stay in the hospital [ Time Frame: An average of 4 days ]
    length of stay in the hospital from admission to discharge of patient after surgery.

  3. The amount of postoperative pain. [ Time Frame: Within 2-4 weeks of surgery ]
    The amount of postoperative patient assessment of pain as measured by patient satisfaction survey on 2-4 weeks post-op clinic follow-up.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-99 years
  • Undergo minimally invasive thoracic surgery at UTMB
  • Weight > 50 kg
  • Written informed consent obtained from subject

Exclusion Criteria:

  • Hepatic dysfunction
  • Renal dysfunction
  • Chronic alcohol consumption
  • Acetaminophen sensitivity
  • Opioid tolerance
  • History of chronic pain
  • Vulnerable populations including pregnant and prisoners
  • Extension into an extrathoracic compartment (i.e. minimally invasive esophagectomy), or concomitant chest wall resection

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): NCT03051932


Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Mallinckrodt
Investigators
Layout table for investigator information
Principal Investigator: Ikenna Okereke, MD University of Texas Medical Branch at Galveston
Layout table for additonal information
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03051932    
Other Study ID Numbers: 16-0340
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics