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OpenTrials
Completed

NCT Number: NCT03558555

Determine the Clinical Advantage of IV vs PO Acetaminophen

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai West Hospital

New York, 10019, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetaminophen IV Soln

Drug

1000mg of IV acetaminophen

Oral acetaminophen

Drug

oral acetaminophen 975mg pills

Placebo pills

Drug

placebo match to acetaminophen

Saline

Drug

Intravenous saline

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yan Lai

Other

Registry information

Official study title

Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2018
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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