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Title: The critical assessment of methodologies used in support of paediatric pharmacokinetic studies
Author: Mohammed, Baba Suleman
ISNI:       0000 0004 2709 7084
Awarding Body: University of Aberdeen
Current Institution: University of Aberdeen
Date of Award: 2010
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The aims were to critically assess methodologies relevant to PK studies tailored to the needs of children. In view of the significant challenges associated with pain control in children paracetamol and ketorolac were selected for the study. Methods: Two bioanalytical methods were developed to measure paracetamol and enantiomers of ketorolac in paediatric samples, to support PK studies of IV paracetamol and ketorolac in children less than 16 years old. All studies had ethical approval and clinical trial authorisation. Results: The developed bioanalytical methods were reliable, requiring only 30 μl of blood for paracetamol, and 50 μl of plasma for ketorolac. Paracetamol concentrations from finger-prick samples in the first hour post dose were greater than from venous samples (349% at 15, 72% at 30, and 9.3% at 60minutes). There were no differences in median CL (0.41, 0.31 and 0.37 1h-1kg-1), Vd (0.90, 0.95 and 0.90 1/kg) and t1/2 (1.7, 2.2 and 1.6 h) among the respective age groups 2-5, 6-10 and 11-15 years. All PK parameters were different for R- and S- ketorolac, with Vd and CL of R- being lower than those of S- (0.12 vs. 0.17 1/kg; 0.017 vs. 0.049 1/h/kg). The median half-life of R- was longer than that of S- (5.0 vs. 3.1 h, P = 0.043). Conclusions: Bioanalytical method did not limit PK trials in children. Sampling method affected PK parameter estimation, and prolonging cannula patency was the most challenging procedure during blood sampling. The PK of IV paracetamol was similar in children 2-15 years old, and the enantiomers of ketorolac were found to have different PKs in children.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available
Keywords: Pharmacokinetics ; Children ; Child health ; Drugs