se of intravenous tapentadol solution for injection for pain after surgery in children from newborn to less than 2 years old, including preterm babies.
- Conditions
- Severe post-operative painTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]MedDRA version: 17.1Level: LLTClassification code 10036286Term: Post-operative painSystem Organ Class: 100000004863
- Registration Number
- EUCTR2014-002259-24-ES
- Lead Sponsor
- Grünenthal GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
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
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.
14. Subject has clinically relevant abnormal lab values from a sample obtained postoperatively
and prior to allocation to IMP. The following specifications apply:
? Aspartate transaminase or alanine transaminase is greater than 2.5-times upper limit of normal.
? For age subgroup 1 and age subgroup 2, total bilirubin is greater than 2-times upper limit of normal and direct bilirubin greater than 20% of the total bilirubin.
? For age subgroup 3 and age subgroup 4, total bilirubin is outsi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method