NCT02244619

PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement

Randomized, Double-Blind, Study Comparing Oral Acetaminophen Plus Intravenous (IV) Placebo to Oral Placebo Plus IV Acetaminophen Given Perioperatively for Controlling Pain in the 24hr Post-op Period After Total Hip or Knee Joint Replacement

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 515 (actual)
• Sponsor: Kettering Health Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen

Detailed description

Subjects will be randomized to receive perioperative dosing of either: 1. Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR, 2. IV acetaminophen (Ofirmev) 1000mg/100ml with Oral Placebo (oral capsules). Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery.

Conditions

• Post-op Pain

Interventions

Type	Name	Description
DRUG	Oral acetaminophen	Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.
DRUG	IV acetaminophen	Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-09-19
• Last updated: 2017-07-24
• Results posted: 2017-07-24

Locations

1 site across 1 country: United States