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Completed

NCT Number: NCT03468920

Preoperative IV Versus Oral Acetaminophen

The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

TriHealth, Bethesda Butler Hospital

Cincinnati, Ohio, 45011, United States

About this study

This study will use a randomized, double-blind, controlled design with two arms:

Arm 1: Scheduled IV Acetaminophen and PO placebo provided preoperatively Arm 2: Scheduled PO Acetaminophen and IV placebo provided preoperatively

120 patients will be randomized 1:1 into Arm 1 or Arm 2. All other care, except route of preoperative Acetaminophen, will follow standard care procedures. The following outcome measures will be collected: postoperative pain, postoperative opioid medication administration, postoperative nausea and vomiting, occurrence of respiratory depression postoperatively, occurrence of administration of reversal agent postoperatively, length of stay in recovery room, patient satisfaction with pain control.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years old or older
  • Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical procedure performed under general anesthesia

Exclusion criteria

  • Allergy to Acetaminophen
  • Lactose intolerance or lactose allergy (placebo capsules contain lactose)
  • Hepatic disease
  • Having taken a product containing acetaminophen within 6 hours of scheduled surgery time
  • Pregnant
  • Weight less than 50kg
  • Opioid addiction - admits to current opioid addiction and/or substance abuse disorder, and/or currently in treatment for opioid addiction or substance abuse
  • Emergent or on-call procedures
  • Inpatient surgery

Treatment and study plan

IV acetaminophen

Drug

IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively

Other names: Tylenol

PO Acetaminophen

Drug

Acetaminophen PO 1000mg once pre-operatively

Other names: Tylenol

PO Placebo

Drug

PO placebo capsule compounded to match PO Acetaminophen capsule

IV Solution Placebo

Drug

This will serve as the placebo for the IV Acetaminophen intervention

Other names: IV Normal Saline

Primary outcomes

  1. Patient Reported Pain

    Time frame: through study visit, less than 24 hours

    Pain measured from 0 (no pain) to 10 (worst pain)

Secondary outcomes

  1. Number of Participants Who Received Opioid Administration in PACU

    Time frame: through study visit, less than 24 hours

    Number of Participants who Received Opioid Administration in PACU

  2. Number of Participants Who Experienced Postoperative Nausea and Vomiting

    Time frame: through study visit, less than 24 hours

    Did patient experience negative effects of pain medication (postoperative nausea and vomiting)

  3. Length of Stay

    Time frame: through study visit, less than 24 hours

    Minutes from entering PACU to end of Phase II

  4. Patient Satisfaction

    Time frame: up to 2 days after surgery

    Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2018
Registry last updated
May 14, 2019

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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