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This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years. The proposed number of study participants by subset is: 8 paediatric participants 1-2 years; 8 paediatric participants >2-6 years and 9 paediatric participants >6-17 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | a target dose of intranasal sufentanil 0,5 mcg/kg + ketamine 0,5 mg/kg, (2-4 puffs) and an additional dose if needed as premedication before placement of a PVC for induction of anaesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT001 | Combination Product | Sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg as nasal spray, followed by an additional dose 10 -15 minutes after, if needed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total absorption over time | Area under the concentration vs time curve | 0 - 120 minutes |
| Maximum absorption | Peak concentration (Cmax) | 0 - 120 minutes |
| Distribution | Volumen of distribution (Vd) | 120 - 240 minutes |
| Elimination | Half life (T½) | 120 - 240 minutes |
| Elimination | Clearance, | 120 - 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Analgetic effect | pain intensity by age-appropriate scale in relation to the placement of peripheral venous catheter | 0 - 1 hour |
| Sedation | Assessment of sedation at the time of placement of the peripheral venous catheter using the University of Michigan Sedation Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Volker Classen, MD | Department of Anaesthesiology, The Juliane Marie Centre Copenhagen University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anæstesi- og Operationsafdelingen 4013 Juliane Marie Centeret | Copenhagen | Region H | 2100 | Denmark |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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The study population will receive a target dose of intranasal CT001 corresponding to sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg (and an additional dose 10 -15 minutes after, if needed) prior to an elective surgical, procedure.
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| 0 - 1 hour |
| Feasibility, (Acceptance of intranasal administration) | Acceptance of the intranasal route of administration by the child, assessed by the child or legally acceptable representative or health care provider. | 0- 4 hours |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |