se of intravenous tapentadol solution for injection for pain after surgery in children from newborn to less than 2 years old, including preterm neonates.
- Conditions
- Severe post-operative painMedDRA version: 20.0 Level: LLT Classification code 10036286 Term: Post-operative pain System Organ Class: 100000004863Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2014-002259-24-DE
- Lead Sponsor
- Grünenthal GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 31
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
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 subgroup
1 and 2.
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