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

Phase 4

Completed

• Conditions: Post-op Pain
• Interventions: Drug: Oral acetaminophen; Drug: IV acetaminophen

• Registration Number: NCT02244619
• Lead Sponsor: Kettering Health Network

Brief 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-19
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2017-05-17
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-21
• Last Update Submitted: 2017-07-21
• Results First Posted: 2017-07-24
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 515

Inclusion Criteria

• 18 years of age and older
• Able to provide written consent
• Able to read and write in English
• Weighing over 50 kg
• Will undergo total hip or total knee joint replacement

Exclusion Criteria

• Non-verbal patients
• Unable to use numeric pain scale
• Allergic to the test article
• Documented hepatic impairment or failure
• Current illicit drug use
• Requires traumatic or emergent surgery
• Pregnant women
• Women who are breastfeeding
• Prisoners
• Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA)
• Unable to swallow oral capsules

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral acetaminophen	Oral acetaminophen	Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
IV acetaminophen	IV acetaminophen	Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

Primary Outcome Measures

Name	Time	Method
Total Post-operative Use of Opioids	During post-op period up to 24 hrs after surgery	Post-operative use of opioids, measured in morphine milligram equivalent (MME) units

Secondary Outcome Measures

Name	Time	Method
Patient-rated Pain in the Post-operative Period	Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery	Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.

Trial Locations

Locations (1)

Kettering Medical Center; 🇺🇸 Kettering, Ohio, United States