Moderate to Severe Acute Postoperative Pain Clinical Trial
Official title:
Open-label Evaluation of the Population Pharmacokinetic Profile, Safety, Tolerability, and Efficacy of Tapentadol Oral Solution for the Treatment of Post-surgical Pain in Children Aged From Birth to Less Than 2 Years
This is a multicenter, open-label (all people involved know the identity of the
intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are
absorbed in the body, how are they distributed within the body and how are they removed from
the body over time) in children aged from birth to less than 2 years after a surgical
procedure that routinely produces moderate to severe acute post-surgical pain.
The trial will also evaluate the safety and tolerability of tapentadol oral solution in the
population studied and the effect of tapentadol oral solution on pain.
This clinical trial has 3 phases: enrollment, treatment (15 hours) and follow up.
During the enrolment phase consent and eligibility will be determined. After surgery, the
participant will be given routine pain medication as per standard of care in the hospital.
Treatment phase: When the participant has a functioning gastrointestinal tract after surgery,
can tolerate medication administered orally or via a feeding tube, meets the inclusion
criteria, and does not meet any exclusion criterion, the participant will be allocated to the
investigational medicinal product (IMP). Evaluations will be performed over the next 15
hours, including the assessment of the amount of pain. During this time, 2 blood samples will
be taken for testing of the amount of tapentadol and its main metabolites in the
participant's blood.
A final follow-up visit is planned to take place up to 2 weeks after taking the trial
medication.
;