Conditions: Moderate to Severe Acute Postoperative Pain
Keywords: Post-surgical pain Opioid
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Tapentadol 4 mg/mL immediate release oral solution, single dose post-operatively.

Interventions: intervention 1: Tapentadol
Intervention descriptions: intervention 1: None

Protocol document: