Preoperative IV Versus Oral Acetaminophen

• ClinicalTrials.gov Identifier: NCT03468920
• Recruitment Status: Completed
• First Posted: March 19, 2018
• Results First Posted: May 7, 2019
• Last Update Posted: May 14, 2019
• Sponsor: TriHealth Inc.
• Information provided by (Responsible Party): Rachel Baker, TriHealth Inc.

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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.:

Study Protocol and Statistical Analysis Plan  [PDF] March 1, 2018

More Information

• Responsible Party: Rachel Baker, Nurse Researcher, TriHealth Inc.
• ClinicalTrials.gov Identifier: NCT03468920 History of Changes
• Other Study ID Numbers: 17-114
• First Posted: March 19, 2018
• 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

• 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:

Acetaminophen; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics