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

Kettering Health Network

Status and phase: Completed; Phase 4

Conditions: Post-op Pain

Treatments: Drug: IV acetaminophen; Drug: Oral acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT02244619

KMCPH-13-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 515 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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515 participants in 2 patient groups

Oral acetaminophen

Active Comparator group

Description:

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.

Treatment:

Drug: Oral acetaminophen

IV acetaminophen

Active Comparator group

Description:

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.

Treatment:

Drug: IV acetaminophen