Severe post-operative pain MedDRA version: 20.0 Level: LLT Classification code 10036286 Term: Post-operative pain System Organ Class: 100000004863
Conditions
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject’s parent(s) or legal guardian(s) have given written informed consent to participate. 2. Male or female subject aged from birth to less than 2 years, including preterm neonates. 3. For subjects in age subgroup 3: Gestational age at least 37 weeks. For subjects in age subgroup 4: A gestational age of 24 weeks to less than 37 weeks with a postmenstrual age of less than or equal to 41 weeks. 4. (Criterion deleted) 5. Subject is not obese (e.g., a body weight above the 97th percentile range for children based on the World Health Organization weight charts, with a minimum body weight of 1.5 kg. 6. Physical status rated not higher than P3 on the American Society of Anesthesiologists physical status classification in subjects in age subgroup 1 and age subgroup 2. 7. Subject has undergone a qualifying procedure (surgery or alternatively for subjects in age subgroup 4, a medical procedure) that, in the investigator’s opinion, would reliably produce moderate to severe pain requiring opioid treatment. 8. Subjects in age subgroup 3 or age subgroup 4 must be in an intensive care unit or comparable unit with high medical surveillance. 9. At the time of allocation to Investigational Medicinal Product, subject has a sedation score that is not higher than 2 (moderately sedated) on the University of Michigan Sedation Scale with the exception of subjects who are mechanically ventilated in age subgroup 3 and age subgroup 4. 10. Subject has a reliable venous vascular access for pharmacokinetic blood sampling. Are the trial subjects under 18? yes Number of subjects for this age range: 32 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject’s parent(s) or legal guardian(s) is an employee of the investigator or trial site with direct involvement in trials under their direction, or is a family member of the employees or the investigator. 2. Subject has been previously exposed to tapentadol. 3. Subject has received an experimental drug/device within 28 days before allocation to IMP, or less than 10 times the drug’s half-life, whichever is longer. 4. Concomitant participation in another clinical trial with an experimental drug or experimental device for the duration of this trial. 5. Subject has undergone brain surgery. 6. (Criterion deleted) 7. Subject has a history or current condition of seizure disorder or traumatic or hypoxic brain injury or other conditions that may increase the intracranial pressure. 8. Subject has a history or current condition of moderate to severe renal or hepatic impairment or respiratory conditions that would put the subject at risk for developing respiratory depression. 9. Subject has signs or symptoms of congestive heart failure or hemorrhagic disorder following surgery. 10. Subject has a concomitant disease or disorder that in the opinion of the investigator can affect or compromise subject’s safety during the trial participation. 11. Subject has cognitive or developmental impairment that would affect trial participation. 12. Subject has a clinically relevant history of hypersensitivity, allergy, or contraindication to tapentadol (or ingredients). 13. Subject has clinically relevant abnormal ECG in the investigator’s judgment or QTcF >460 ms (unless value is a consequence of cardiac surgery and is not considered clinically significant). 14. Subject has clinically significant abnormal laboratory values or exclusionary hepatic or renal parameters, or pathological jaundice. 15. Sepsis that requires treatment with catecholamines. 16. Subject has been administered a prohibited medication. 17. The mother of a newborn subject or the breastfeeding mother of a subject was administered a prohibited medication. 18. Subject has post-operative clinically unstable vital signs, or clinically unstable respiratory condition (unless subject is mechanically ventilated in age subgroup 3 and 4). 19. Peripheral oxygen saturation <92% (acyanotic subjects) or <75% (cyanotic subjects) with or without oxygen administration or for age sub-group 4 a clinically significant decrease in oxygen saturation at the time of allocation to IMP. 20. Subject requires continuous positive airway pressure or mechanical ventilation, at the time of allocation to IMP, for subjects in age sub-group 1 and 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to collect serum concentration data of tapentadol and its major metabolite tapentadol-O-glucuronide after the administration of a single dose of intravenous tapentadol solution for injection in children aged from birth to less than 2 years, including preterm neonates, after a qualifying procedure (either a surgical procedure or alternatively a medical procedure in preterm neonates) that routinely produces moderate to severe acute pain requiring opioid treatment. The concentration data will be used to characterize the pharmacokinetic parameters of tapentadol using population and physiologically-based pharmacokinetic approaches. This will enable data based recommendations for the use of tapentadol in children of different ages. ; Secondary Objective: To evaluate the safety and tolerability of a single dose of tapentadol intravenous solution in the population studied. To explore the effect of intravenous tapentadol solution for injection on moderate to severe pain that, in the opinion of the investigator, requires treatment with an opioid, using validated age appropriate scales. ; Primary end point(s): • Pharmacokinetic evaluation based on serum concentrations of tapentadol, and • Pharmacokinetic evaluation based on serum concentrations of tapentadol-O-glucuronide. ; Timepoint(s) of evaluation of this end point: Blood samples taken within 10 hours of IMP intake at 3 time points per subject. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No secondary endpoints;Timepoint(s) of evaluation of this end point: No secondary endpoints | — |
Countries
Czech Republic, France, Germany, Hungary, Poland, Spain, United Kingdom
Contacts
Public ContactGrünenthal Clinical Trial Helpdesk
Grünenthal GmbH
Outcome results
None listed