Caldolor Versus Caldolor Plus OFIRMEV in Total Knee or Hip Arthroplasty Surgeries

NCT01773005 | Completed Phase 4

• 2 other identifiers: CP-001-1220121232
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the effectiveness and of perioperative use of Caldolor alone and in combination with OFIRMEV in total knee or hip arthroplasty procedures.

Conditions

Pain

Keywords

Anesthetics, Intravenous

Outcome Measures

Primary Outcomes (1)

• Visual Analog Score (VAS)

  First Post-op 100mm VAS pain score at rest and with movement

  Before surgery to Post-operative Day 5 (or Hospital Discharge)

Secondary Outcomes (1)

• Quality of Recovery (QoR40 scale)

  Post-operative Day one

Other Outcomes (1)

• Side effects

  Post-operative Day one to five (or hospital discharge)

Study Arms (2)

Caldolor

SHAM COMPARATOR

Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia, followed by 800 mg Caldolor every 6 hours until discharge or for a total of up to 120 hours (5 days)

Drug: Caldolor

Ofirmev

ACTIVE COMPARATOR

Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia and intravenous Acetaminophen (1000 mg Ofirmev) at the time of surgical wound closure, followed by 800 mg Caldolor plus 1000 mg Ofirmev every 6 hours until discharge for a total of up to 120 hours (5 days)

Drug: Ofirmev; Drug: Caldolor

Interventions

Ofirmev DRUG

Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia and intravenous Acetaminophen (1000 mg Ofirmev) at the time of surgical wound closure, followed by 800 mg Caldolor plus 1000 mg Ofirmev every 6 hours until discharge for a total of up to 120 hours (5 days)

Also known as: Intravenous Acetaminophen

Ofirmev

Caldolor DRUG

Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia, followed by 800 mg Caldolor every 6 hours until discharge or for a total of up to 120 hours (5 days)

Also known as: Intravenous Ibuprofen

Caldolor; Ofirmev

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients age 18-70 scheduled for total knee or hip arthroplasty surgery
• American Society of Anesthesiology physical status I, II, III

You may not qualify if:

• Impaired liver function
• History of substance abuse or chronic pain
• Patients known to be hypersensitive to any of the components of Caldolor or Ofirmev
• Patients less than 18 years of age.
• Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]) and agree to abide by the study restrictions.
• Be pregnant or nursing
• Be otherwise unsuitable for the study, in the opinion of the Investigator.

Sponsors & Collaborators

• Anita Gupta: lead
• Cumberland Pharmaceuticals: collaborator

Study Sites (1)

University Pain Institute Hahnemann Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Kirtanaa Voralu, MS

  Associate Director Research Management

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 21, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 29, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)