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Table 3 Schedule of activities

From: Comparison of three regimens with inhalational methoxyflurane versus intranasal fentanyl versus intravenous morphine in pre-hospital acute pain management: study protocol for a randomized controlled trial (PreMeFen)

Timepoint

T(x)

T0

T5

T10

T20

T30

TED

Within 14 days

Description

Scene arrival

IMP adm

5 min

10 min

20 min

30 min

Arrival ED

 

Inclusion and exclusion criteria

X

       

Informed oral consent

X

       

Physical examination including estimation of weight

X

       

Medical history

X

       

Allocation

X

       

ECG (If chest pain)

(X)

     

(X)

 

Intravenous access attempts

X

       

Start administration of IMP

 

X

      

SpO2

X

  

X

X

X

X

 

Blood pressure

X

  

X

 

X

X

 

Heart rate

X

  

X

X

X

X

 

Respiration rate

X

  

X

 

X

X

 

NRS

X

 

X

Primary endpoint

X

X

X

 

GCS

X

  

X

 

X

X

 

Patient satisfaction Likert scale

      

X

 

HCP satisfaction Likert scale

      

X

 

Troponin I/T

      

X

 

Recording final diagnosis

       

X

  1. IMP Investigational medicinal product, ECG Electrocardiogram, SpO2 Oxygen saturation, NRS Numeric rating scale, GCS Glasgow come scale, HCP Health care personnel