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

NCT ID: NCT02244619

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-04-30

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.

Conditions

Post-op Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Oral acetaminophen

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

IV acetaminophen

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Tylenol; Ofirmev

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kettering Health Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sidney (Skip) Hickman, RPh

Role: PRINCIPAL_INVESTIGATOR

Kettering Health Network

Locations

Kettering Medical Center

Kettering, Ohio, United States

Countries

United States

Other Identifiers

KMCPH-13-001

Identifier Type: -

Identifier Source: org_study_id