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Table 1 Study event flowchart

From: Comparing efficacy and safety between Naldebain® and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial

Period

Screening

Study period

Study day

−30 to −1

−1

0

1

2

3–5

6

Discharge

Informed consent

X

       

Medical history

X

       

Demographic data

X

       

Physical examination

X

      

X

Vital signs

X

X

X

X

X

X

X

Xd

Injection site evaluation

 

Xb

Xb

Xb

Xb

Xb

Xb

Xb,d

Laboratory tests

X

Xa

     

X

12-lead ECG/chest x-ray

X

       

Inclusion/exclusion criteria

 

X

      

Randomization

 

X

      

Naldebain® administration

 

Xb

      

Surgery

  

X

     

Pain assessment

 

X

X

X

X

X

X

 

BPI

 

X

  

X

 

X

 

Patient satisfaction

       

X

Concomitant medication

X

X

X

X

X

X

X

Xd

Adverse event record

 

X

X

X

X

X

X

Xd

Drug accountability for fentanyl

  

Xe

Xe

Xe

   

Discharge

       

Xc

End of study

       

X

  1. BPI brief pain inventory, ECG electrocardiogram
  2. aAdditional laboratory tests are requested as required by the investigator
  3. bOnly for subjects who are randomized to the Naldebain® group
  4. cPatients can discharge on day 6–30; patients still hospitalized after day 6 do not serve as a protocol deviation/violation or serious adverse event
  5. dFor patients who are discharged on day 6, the assessment is performed only once
  6. eOnly for subjects who are randomized to the patient-controlled analgesia (PCA) group