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. 2024 Mar 5;41(5):381–390. doi: 10.1097/EJA.0000000000001966

Table 5.

Summary results for the laboratory simulation of preparation, reconstitution and administration times in cannulas representative of an adult patient and a paediatric patient

NPJ5008 120 mg per vial Dantrium® 20 mg per vial Time difference (Dantrium® – NPJ5008 time)
Mean (min to max) preparation of water for injection (WFI)a time (n = 10) (s) 34 (29 to 51) 46 (38 to 62) 12
Mean (min to max) reconstitutionb time (n = 10) (s) 32 (29 to 40) 73 (55 to 86) 41
Mean (min to max) draw upc time (n = 10) (s) 38 (30 to 49) 62 (51 to 98) 24
Mean (min to max) total drug preparationd time (n = 10) (seconds) 104 (88 to 140) 181 (144 to 246) 77
Cannula gauge 16 (adult) 22 (child) 16 (adult) 22 (child)
Mean (min to max) administratione time (n = 5) (s) 6 (5 to 7) 15 (14 to 18) 12 (11 to 13) 48 (44 to 55) 16 gauge: 6
22 gauge: 33
Average total time (n=5)f 1 min 53 s 1 min 57 s 3 min 0 s 4 min 2 s
a

Preparation for NPJ5008 is: remove the cap from the NPJ5008 vial; remove the 20 ml syringe from its packaging; remove a sterile needle from its packaging and add to the syringe; open the bottle of WFI and withdraw 20 ml of the WFI into the syringe. Preparation for Dantrium® is: remove the cap from the Dantrium® vial; remove the 60 ml syringe from its packaging; remove a sterile needle from its packaging and add to the syringe; open the bottle of WFI and withdraw 60 ml of WFI into the syringe.

b

Reconstitution is: reconstitute the vial with the filled syringe; shake until the powder has been reconstituted.

c

Draw up is: using the same syringe and needle, collect all the solution from within the vial. Introduce 20 ml of air via the needle in order to equilibrate pressure within the vial; attach the filled syringe to the cannula via the Luer lock. For Dantrium® only draw up time also includes preparation of the filter needle spike device.

d

Total drug preparation time is the sum of the previous three steps (preparation, reconstitution, draw up).

e

Administration is: administer the solution via the cannula into a labelled glass beaker.

f

The average total time is not a sum of the average data per step, but represents the average total time taken for the n = 5 that used each cannula gauge type.