NCT03468920

Preoperative IV Versus Oral Acetaminophen

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	IV Acetaminophen	IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively
DRUG	PO Acetaminophen	Acetaminophen PO 1000mg once pre-operatively
DRUG	PO Placebo	PO placebo capsule compounded to match PO Acetaminophen capsule
DRUG	IV Solution Placebo	This will serve as the placebo for the IV Acetaminophen intervention

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-02-14
• Completion: 2019-04-12
• First posted: 2018-03-19
• Last updated: 2019-05-14
• Results posted: 2019-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study