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Determine the Clinical Advantage of IV vs PO Acetaminophen

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. Identifier: NCT03558555
Recruitment Status : Completed
First Posted : June 15, 2018
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Information provided by (Responsible Party):
Yan Lai, Icahn School of Medicine at Mount Sinai

Brief Summary:
There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Drug: Acetaminophen IV Soln Drug: Oral Acetaminophen Drug: Placebo Pills Drug: Saline Phase 4

Detailed Description:
In previous literature it has been shown that compared to placebo, IV acetaminophen can improve postoperative pain scores and reduce opioid requirements. In addition, IV acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative effectiveness trials of IV vs PO administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be conducted to determine possible clinical advantages.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants presenting for inguinal hernia surgery are assigned to either the oral or intravenous acetaminophen group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery
Actual Study Start Date : December 8, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Oral Acetaminophen
Patients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively.
Drug: Oral Acetaminophen
oral acetaminophen 975mg pills

Drug: Saline
Intravenous saline

Active Comparator: Acetaminophen IV Soln
Patients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively.
Drug: Acetaminophen IV Soln
1000mg of IV acetaminophen

Drug: Placebo Pills
placebo match to acetaminophen

Primary Outcome Measures :
  1. PACU Visual Analogue Pain Scores [ Time Frame: baseline, 1 hour, and Day 1 discharge ]
    Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.

  2. Total MME Intraoperatively [ Time Frame: Day 1 ]
    Total Morphine Milligram Equivalent (MME) use intraoperatively

  3. Total Narcotic Use in PACU. [ Time Frame: Day 1 ]
    Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)

Secondary Outcome Measures :
  1. PACU Length of Stay [ Time Frame: up to 24 hours after PACU arrival ]
    Time in PACU

  2. Patient Reported Total Narcotic Use Post-discharge [ Time Frame: average 7 days ]
    home opiod use

  3. Patient Satisfaction. [ Time Frame: 7 days post surgery ]
    Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • ASA scores I-III
  • Ambulatory surgery patients
  • Ages 18-75
  • Surgeries requiring general anesthesia for hernia surgery

Exclusion Criteria:

  • Patients with contraindications to acetaminophen (history of end organ liver dysfunction)
  • Known allergy to acetaminophen
  • Emergency surgery
  • Patients who were not fasted
  • Patients who cannot tolerate PO
  • Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen
  • Pregnancy
  • Weight less than 50kg
  • Chronic daily narcotic use
  • Patients who's anesthetic plan requires regional anesthesia
  • Patient refusal to participate or do not have capacity to provide consent.

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 identifier (NCT number): NCT03558555

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United States, New York
Mount Sinai West Hospital
New York, New York, United States, 10019
Sponsors and Collaborators
Yan Lai
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Principal Investigator: Yan Lai, MD, MPH Icahn School of Medicine at Mount Sinai
  Study Documents (Full-Text)

Documents provided by Yan Lai, Icahn School of Medicine at Mount Sinai:
Publications of Results:
Other Publications:
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Responsible Party: Yan Lai, Assistant Professor of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai Identifier: NCT03558555    
Other Study ID Numbers: GCO 16-1763
IF#16-1763 ( Other Identifier: Icahn School of Medicine at Mount Sinai )
IF#2175834 ( Other Identifier: Icahn School of Medicine at Mount Sinai )
First Posted: June 15, 2018    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: February 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yan Lai, Icahn School of Medicine at Mount Sinai:
Intravenous versus oral
Additional relevant MeSH terms:
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Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs