Preoperative IV Versus Oral Acetaminophen

TriHealth

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: PO Acetaminophen; Drug: IV Solution Placebo; Drug: IV Acetaminophen; Drug: PO Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03468920

17-114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Arm 1: IV Acetaminophen group

Experimental group

Description:

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

Treatment:

Drug: IV Acetaminophen

Drug: PO Placebo

Arm 2: PO Acetaminophen group

Active Comparator group

Description:

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

Treatment:

Drug: IV Solution Placebo

Drug: PO Acetaminophen