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

Post-op Pain Clinical Trial

— KHEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244619
• Other study ID #: KMCPH-13-001
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2014
• Last updated: July 21, 2017
• Start date: September 2014
• Est. completion date: April 2016

Study information

• Verified date: July 2017
• Source: Kettering Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-op Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kettering Medical Center	Kettering	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Kettering Health Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-operative Nausea and Vomiting		During post-op period up to 24 hrs after surgery
Other	Time to First Ambulation - 10 Feet		During post-op period up to 24 hours after surgery
Other	Time to First Rescue Opioid (PRN Order)		During post-op period up to 24 hrs after surgery
Primary	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	Patient-rated Pain in the Post-operative Period	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.	Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery