Table 4.
Body size-adjusted model population pharmacokinetic parameters of R (+) (OFV −207.867) and S (−) (OFV −339.784) Ketorolac in 8 infants aged 2.5–6 months combined with previously studied dataset comprising 25 infants and toddlers (aged 6–18 months).
Parameter Estimates | Between-Subject Variability | |||
---|---|---|---|---|
Valuea (θ) | S.E.(%)b | BSVc (ω) | S.E (%).b | |
R (+) Ketorolac | ||||
CL (ml/min/kg) | 1.56 | 8.72 | 0.208 | 32.7 |
V1 (ml/kg) | 131 | 9.08 | 0.287 | 20.0 |
Q (ml/min/kg) | 1.29 | 14.19 | NE | NE |
V2 (ml/kg) | 79.5 | 16.6 | 0.322 | 59.9 |
σ2 | ||||
Proportional | 0.0312 | 23.9 | ||
Additive | 0.00430 | 47.9 | ||
S (−) Ketorolac | ||||
CL (ml/min) | 7.8 | 11.71 | 0.378 | 30.9 |
V1 (ml) | 218 | 12.66 | 0.381 | 21.3 |
Q (ml/min) | 19.2 | 3.82 | NE | NE |
V2 (ml) | 44.9 | 25.17 | 1.56 | 30.6 |
σ2 | 0.0176 | 59.7 |
Fixed-effect parameters: clearance (CL), central volume of distribution (V1), inter-compartmental clearance (Q) and peripheral volume of distribution (V2). Residual error parameters: variance of the exponential error model for R (+) ketorolac and variance of the additive error model for S (−) ketorolac. NE, not estimated.
Standard error expressed as percent coefficient of variation.
BSV, between-subject variability expressed in variance units (approximately coefficient of variation squared).