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

NCT02244619 | Completed Phase 4 Results

• 1 other identifier: KMCPH-13-001
• Study Type: interventional
• Target: 515
• Locations: 1 country
• Sites: 1

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

Conditions

Post-op Pain

Keywords

Hip replacement; Knee replacement; randomized trial; acetaminophen; post-op pain management

Outcome Measures

Primary Outcomes (1)

• Total Post-operative Use of Opioids

  Post-operative use of opioids, measured in morphine milligram equivalent (MME) units

  During post-op period up to 24 hrs after surgery

Secondary Outcomes (1)

• 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

Other Outcomes (3)

• Post-operative Nausea and Vomiting

  During post-op period up to 24 hrs after surgery

• Time to First Ambulation - 10 Feet

  During post-op period up to 24 hours after surgery

• Time to First Rescue Opioid (PRN Order)

  During post-op period up to 24 hrs after surgery

Study Arms (2)

Oral acetaminophen

ACTIVE COMPARATOR

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.

Drug: Oral acetaminophen

IV acetaminophen

ACTIVE COMPARATOR

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.

Drug: IV acetaminophen

Interventions

Oral acetaminophen 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.

Also known as: Tylenol

Oral acetaminophen

IV acetaminophen 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.

Also known as: Ofirmev

IV acetaminophen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kettering Health Network: lead

Study Sites (1)

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Single hospital, limited to two types of surgical patient. No standard protocol for assessing pain. Oral acetaminophen administered earlier than IV per hospital protocol.

Results Point of Contact

• Title: Skip Hickman, RPH
• Organization: Kettering Health Network

skip.hickman@ketteringhealth.org

(937) 762-1339

Study Officials

• Sidney (Skip) Hickman, RPh

  Kettering Health Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 19, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 24, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)