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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000310-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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The study will assess the efficacy of fentanyl using a pharmacokinetic/pharmacodynamic (PK/PD) model where the concentration of the drug is related to effect curve (pain score change in response to standardized procedural pain). Further cortical, physiological and biochemical responses to fentanyl will be assessed, elucidating the feasibility before the main study project (NeoOpioid) start.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl for procedural pain | Experimental | A dose of Fentanyl 5 microgram/ml, 0.5 microgram/kg (anticipated medium pain) or 2 microgram/kg (anticipated strong pain) will be given prior to a painful procedure during NICU-care. Repeated doses or complementary analgesics will be administered according to pain assessment and clinical judgement. This is not an RCT with several arms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl (5 microgram/ml) prediluted ampoules | Drug | Bolus; Fentanyl (5 microgram/ml) 0,5 microgram/kg (0.1 ml/kg) is administered over 1 min starting 3-5 min before the lighter skin breaking procedure. Fentanyl (5 microgram/ml) 2 microgram/kg is administered over 10 min before the start of the more painful procedur ( pleura drainage or tracheal intubation). |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics; fentanyl clearance | Serum concentration will be analysed and the clearance will be calculated with NONMEM pharmacokinetics. | 48 hours |
| Pharmacokinetics; fentanyl clearance | The serum concentration values will be analysed as Area under the curve, AUC | 6 hours |
| Pharmacodynamics; Amplitude integrated electroencephalography (aEEG) | Background activity | 6 hours |
| Pharmacodynamics; Amplitude integrated electroencephalography (aEEG), | Seizure activity | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics, change in vital parameters | Change in heart rate | 6 hours |
| Pharmacodynamics, change in vital parameters | Change in mean arterial blood pressure |
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Inclusion Criteria:
Clinical indication for analgesia before any of following procedures;
Possibility to obtain blood samle after the procedure (indwelling line)
Infants all gestational ages.
Postnatal age 0-28 days
Informed written parental concent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vineta Fellman, Professor | Dep. of Pediatrics, Lund University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit, Skåne University Hospital | Lund | 221 85 | Sweden |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 6 hours |
| Pharmacodynamics, change in vital parameters | Change in near infrared spectroscopy | 6 hours |
| Pharmacodynamics, behavioural response | Pain assessment with the Premature Infant Pain Profile-revised (PIPP) score for procedural pain (0-21, with the highest value if strong pain in extremely preterm infants) | 6 hours |
| Pharmacodynamics, hormonal response | Blood levels of cortisol | 48 hours |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |