Severe post-operative pain MedDRA version: 18.0 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. Gestational age at least 32 weeks. 4. Postnatal age at least 1 week (age subgroup 3 and age subgroup 4). 5. A body weight below the 97th percentile range according to World Health Organization standards, 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. 7. Subject has undergone surgery that, in the investigator’s opinion, would reliably produce moderate to severe pain requiring opioid treatment. 8. Preterm neonatal and neonatal subjects must be on an intensive care unit. 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. 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 this trial or other trials under the direction of that investigator or trial site, or the subject, or subject’s parent(s), or legal guardian(s) 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 or used an experimental medical device within 28 days before allocation to Investigational Medicinal Product (IMP), or within a period less than 10 times the drug’s half-life, whichever is longer. 4. Concomitant participation in another interventional clinical trial for the duration of this trial. 5. Subject has undergone brain surgery. 6. Subject requires prolonged mechanical ventilation (more than 48 hours after surgery) or, the subject is mechanically ventilated at the time of allocation to Investigational Medicinal Product. 7. Subject has a history or current condition of any one of the following: • Seizure disorder. • Traumatic or hypoxic brain injury, brain contusion, intracranial hematoma/hemorrhage, post-traumatic recovery, brain neoplasm, or episode(s) of unconsciousness of more than 24 hours. 8. Subject has a history or current condition of any one of the following: • Moderate to severe renal impairment. • Moderate to severe hepatic impairment. • Clinically relevant abnormal pulmonary function or clinically relevant respiratory disease that in the opinion of the investigator would put the subject at risk for developing respiratory depression. 9. Subject has signs or symptoms of congestive heart failure (e.g., requiring more than minimal inotropic support, an abnormal lactic acid value >2-times upper limit of normal), or hemorrhagic disorder following surgery. • Minimal inotropic medication is defined as: - - Dopamine 3 or more microgram/kg per minute (but not together with epinephrine). - - Epinephrine 0.03 or more microgram/kg per minute (but not together with dopamine). - - Milrinone 0.5 or more microgram/kg per minute or less. 10. Subject has a concomitant disease or disorder (e.g., endocrine, metabolic, neurological, or psychiatric disorder, or a febrile seizure or is at risk of, or has, paralytic ileus) 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 such that trial participation can affect or compromise the subject’s safety, or the subject’s ability to comply with the protocol requirements (as appropriate for the subject’s age), in the investigator’s judgment. Otherwise, subjects with cognitive or developmental impairment can be enrolled in the trial. 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. • QT or corrected QT (QTc) interval >460 ms.
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 surgical procedure 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