Pain Clinical Trial
Official title:
A Multicenter, Open-Label, Safety and Pharmacokinetic Study of Oral Codeine Sulfate Administration in Pediatric Subjects 2 Years Old Through 17 Years Old With Post-procedural Pain
This is a multicenter, open-label study to evaluate the safety and PK of oral codeine sulfate in pediatric subjects with mild to moderate post-procedural pain.
Eligible pediatric subjects will complete all screening procedures within 14 days before the
scheduled procedure. Screening will be permitted on the day of the procedure. At screening,
the subject's parent or guardian will provide written parental permission/informed consent to
participate in the study and subjects will provide assent (if required by the local
Institutional Review Board [IRB]) before any protocol-specified procedures or assessments are
performed.
Subjects may be inpatients, outpatients, or day-surgery patients at the study site who will
undergo procedures expected to result in at least mild to moderate post-procedure pain with
the day of the procedure noted as Day 0, and will be followed until discharge from the study
site.
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|---|---|---|---|
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