Preoperative IV Versus Oral Acetaminophen

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: IV Acetaminophen; Drug: PO Placebo; Drug: PO Acetaminophen; Drug: IV Solution Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45011
      • TriHealth, Bethesda Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Tylenol; Drug: IV Solution Placebo; This will serve as the placebo for the IV Acetaminophen intervention; Other Names: IV Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Pain	Pain measured from 0 (no pain) to 10 (worst pain)	through study visit, less than 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Received Opioid Administration in PACU	Number of Participants who Received Opioid Administration in PACU	through study visit, less than 24 hours
Number of Participants Who Experienced Postoperative Nausea and Vomiting	Did patient experience negative effects of pain medication (postoperative nausea and vomiting)	through study visit, less than 24 hours
Length of Stay	Minutes from entering PACU to end of Phase II	through study visit, less than 24 hours
Patient Satisfaction	Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)	up to 2 days after surgery

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): February 14, 2019
• Study Completion (Actual): April 12, 2019

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 17-114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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