CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-12
SponsorChildren's Hospital of Eastern Ontario

About this trial

Celecoxib is effective for reducing postoperative pain in adults. Children use celecoxib more rapidly than adults and require higher doses. Celecoxib is partially metabolized in the liver by a certain enzyme. A person's genetic variation of this enzyme can influence how well their body uses Celecoxib. Furthermore, Celecoxib down-regulates P-glycoprotein (P-gp), a drug efflux transporter located at the blood brain barrier responsible for central nervous system (CNS) extrusion of ondansetron and possibly fentanyl; therefore celecoxib may augment the CNS effects of these drugs.

Understanding the blood and cerebrospinal fluid (CSF) profile of celecoxib in children and the influence of genetics on metabolism would help to develop appropriate celecoxib dosing in children for various treatment options.

Eligibility criteria

Qualifiers

None

Disqualifiers

Age < 2yrs and >12yrs old

Children with non-hematologic malignancies

AML

Children undergoing a bone marrow aspiration (BMA) only

Trial design

Treatments tested in this trial

  • Celecoxib
  • Placebo

Treatment groups

65 Participants
are divided into 5 treatment groups