This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years. The proposed number of study participants by subset is: 8 paediatric participants 1-2 years; 8 paediatric participants \>2-6 years and 9 paediatric participants \>6-17 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg as nasal spray, followed by an additional dose 10 -15 minutes after, if needed.
Anæstesi- og Operationsafdelingen 4013 Juliane Marie Centeret
Copenhagen, Region H, Denmark
Total absorption over time
Area under the concentration vs time curve
Time frame: 0 - 120 minutes
Maximum absorption
Peak concentration (Cmax)
Time frame: 0 - 120 minutes
Distribution
Volumen of distribution (Vd)
Time frame: 120 - 240 minutes
Elimination
Half life (T½)
Time frame: 120 - 240 minutes
Elimination
Clearance,
Time frame: 120 - 240 minutes
Analgetic effect
pain intensity by age-appropriate scale in relation to the placement of peripheral venous catheter
Time frame: 0 - 1 hour
Sedation
Assessment of sedation at the time of placement of the peripheral venous catheter using the University of Michigan Sedation Score
Time frame: 0 - 1 hour
Feasibility, (Acceptance of intranasal administration)
Acceptance of the intranasal route of administration by the child, assessed by the child or legally acceptable representative or health care provider.
Time frame: 0- 4 hours
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