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Preoperative IV Versus Oral 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: NCT03468920
Recruitment Status : Completed
First Posted : March 19, 2018
Results First Posted : May 7, 2019
Last Update Posted : May 14, 2019
Information provided by (Responsible Party):
Rachel Baker, TriHealth Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: IV Acetaminophen Drug: PO Acetaminophen Drug: PO Placebo Drug: IV Solution Placebo Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will use a randomized, double-blind, placebo controlled design with two arms.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only pharmacy staff will have randomization scheme and be aware of whether patient received oral Acetaminophen with IV placebo OR if the patient received IV Acetaminophen with oral placebo
Primary Purpose: Treatment
Official Title: Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : February 14, 2019
Actual Study Completion Date : April 12, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1: IV Acetaminophen group
Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively
Drug: IV Acetaminophen
IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively
Other Name: Tylenol

Drug: PO Placebo
PO placebo capsule compounded to match PO Acetaminophen capsule

Active Comparator: Arm 2: PO Acetaminophen group
Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively
Drug: PO Acetaminophen
Acetaminophen PO 1000mg once pre-operatively
Other Name: Tylenol

Drug: IV Solution Placebo
This will serve as the placebo for the IV Acetaminophen intervention
Other Name: IV Normal Saline

Primary Outcome Measures :
  1. Patient Reported Pain [ Time Frame: through study visit, less than 24 hours ]
    Pain measured from 0 (no pain) to 10 (worst pain)

Secondary Outcome Measures :
  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)

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT03468920

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United States, Ohio
TriHealth, Bethesda Butler Hospital
Cincinnati, Ohio, United States, 45011
Sponsors and Collaborators
TriHealth Inc.
  Study Documents (Full-Text)

Documents provided by Rachel Baker, TriHealth Inc.:

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Responsible Party: Rachel Baker, Nurse Researcher, TriHealth Inc. Identifier: NCT03468920    
Other Study ID Numbers: 17-114
First Posted: March 19, 2018    Key Record Dates
Results First Posted: May 7, 2019
Last Update Posted: May 14, 2019
Last Verified: May 2019
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs