Preoperative IV Versus Oral Acetaminophen

NCT03468920 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-114
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Patient Reported Pain

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

  through study visit, less than 24 hours

Secondary Outcomes (4)

• 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

  through study visit, less than 24 hours

• Length of Stay

  through study visit, less than 24 hours

• Patient Satisfaction

  up to 2 days after surgery

Study Arms (2)

Arm 1: IV Acetaminophen group

EXPERIMENTAL

Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively

Drug: IV Acetaminophen; Drug: PO Placebo

Arm 2: PO Acetaminophen group

ACTIVE COMPARATOR

Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively

Drug: PO Acetaminophen; Drug: IV Solution Placebo

Interventions

IV Acetaminophen DRUG

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

Also known as: Tylenol

Arm 1: IV Acetaminophen group

PO Acetaminophen DRUG

Acetaminophen PO 1000mg once pre-operatively

Also known as: Tylenol

Arm 2: PO Acetaminophen group

PO Placebo DRUG

PO placebo capsule compounded to match PO Acetaminophen capsule

Arm 1: IV Acetaminophen group

IV Solution Placebo DRUG

This will serve as the placebo for the IV Acetaminophen intervention

Also known as: IV Normal Saline

Arm 2: PO Acetaminophen group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

TriHealth, Bethesda Butler Hospital

Cincinnati, Ohio, 45011, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Nurse Researcher
• Organization: TriHealth

Rachel_Baker2@trihealth.com

513-569-6191

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Researcher

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

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 19, 2018
• Study Start: April 1, 2018
• Primary Completion: February 14, 2019
• Study Completion: April 12, 2019
• Last Updated: May 14, 2019
• Results First Posted: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)