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Table 2 Schedule of events

From: The Opioid Analgesic Reduction Study (OARS)—a comparison of opioid vs. non-opioid combination analgesics for management of post-surgical pain: a double-blind randomized clinical trial

   

Post-Operative Period

Procedures

Screening (Visit 0)

Study Visit 1:  Surgery (Day 1)

Upon Waking in the Morning (Days 2 to 10 +/-5)

When taking Pain Meds (Days 1 to 10 +/-5)

Before Going to Sleep in the Evening (Days 1 to 9 +/-5)

Intermediate Visit / Hospitalization or Fatality Days 1 to 10 (+/- 5)

Post Operative Visit Study Visit 2 (Day 10 +/-5)

Withdrawal or Termination

PDMP Query (Visit 2 plus 186 days +/- 14 days)

Signed Consent Form

X

        

Assessment of Eligibility Criteria (including review of medical history and concomitant medications)

X

X

       

Study Intervention

 

X

X

X

X

    

Pain Assessment

 

X

       

Pain Interference Assessment

    

X

 

X

  

Sleeping Quality

  

X

   

X

  

Assessment of Adverse Events

  

X

 

X

 

X

X

 

Adverse Events and Serious Adverse Event Reporting

     

X

   

Obtain Satisfaction

      

X

  

Determination of Tablets for Diversion

      

X

  

Premature Exit study Documentation

       

X

 

PDMP Inquiry

        

X

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Trials

ISSN: 1745-6215