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We conclude that the doses we administered were safe, but too low. We plan to continue the study with higher doses (0.1 mg/kg iv and 0.2 mg/kg intranasal).
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To assess pharmacokinetics parameters for nalbuphine after intravenous and intranasal administration in infants. Also effect on pain score: Neonatal Infant Pain Score (NIPS) and safety will be evaluated with summary of Adverse Events.
Inclusion criteria are: Infants 29 days-3 months, minimum Body weight 3.0 kg, Indications: septical work up.
Exclusion criteria are: Infants who were born prematurely (before 37 weeks gestation), known kidney or liver disease, known chronic illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous | Active Comparator | single iv application of nalbuphine 0.05mg/kg |
|
| intranasal | Active Comparator | single intranasal application of nalbuphine 0.1mg/kg in infants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalbuphine | Drug | Opioid Pain Medicine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Area under the plasma concentration-time) | Area under the plasma concentration-time from the first to the last sample | One Visit = approximately 6 hours |
| Pharmacokinetics (Maximum Plasma concentration) | Maximum Plasma concentration | One Visit = approximately 6 hours |
| Pharmacokinetics (Time to reach Maximum Plasma concentration) | Time to reach Maximum Plasma concentration | One Visit = approximately 6 hours |
| Pharmacokinetics (Half-life time) | Half-life time | One Visit = approximately 6 hours |
| Pharmacokinetics (Bioavailability of Nalbuphine intranasal) | Bioavailability of Nalbuphine intranasal | One Visit = approximately 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on pain (Neonatal Infant Pain Score) | Effect on pain score: NIPS (Neonatal Infant Pain Score) | One Visit = approximately 6 hours |
| Adverse Events | Safety will be evaluated with summary of Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Berger, Dr | Chlidrens Hospital Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childens Hospital Zurich | Zurich | 8032 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36100355 | Derived | Pfiffner M, Gotta V, Pfister M, Vonbach P, Berger-Olah E. Pharmacokinetics and tolerability of intranasal or intravenous administration of nalbuphine in infants. Arch Dis Child. 2023 Jan;108(1):56-61. doi: 10.1136/archdischild-2022-323807. Epub 2022 Sep 13. |
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if someone ask for IPD
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| One Visit = approximately 6 hours |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |