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Table 1 Schedule of assessments for the SARC trial

From: Salbutamol for analgesia in renal colic: study protocol for a prospective, randomised, placebo-controlled phase II trial (SARC)

Procedures

Screening

Baseline*

Administration of trial medication

Time from start of trial drug administration (min)

Follow-up (h)

15

30

60

120

4

8

12

16

20

24

Eligibility assessment

X

X

          

Demographics

X

           

Informed consent

X

           

ECG

 

X

          

Potassium measurement (K+)

 

X

          

Randomisation

 

X

          

 Respiratory rate

 Oxygen saturations

 Blood pressure

 Heart rate

 

X

X

X

X

X

      

VAS pain score

 

X

X

X

X

X

X

X

X

X

X

X

McGill Questionnaire

 

X

X

X

X

X

      

Adverse event assessments

  

X

X

X

X

X

X

X

X

X

X

Satisfaction Questionnaire+

     

X

      

OPTIMISED SWAT Questionnaire+

     

X

      

Protocol non-compliances

X

X

X

X

X

X

X

X

X

X

X

X

  1. *All baseline assessments should take place immediately prior to the administration of trial treatment
  2. +If the patient is discharged from the emergency department before this time point, these activities may be conducted prior to 120 min
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Trials

ISSN: 1745-6215