Clinical trial NCT04897750: Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures
Official title: Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Analgesia
Lead sponsor: Cessatech A/S
Sponsor class: INDUSTRY
First posted: 2021-05-21
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Paediatric participants, age 1-17 years at the day of the surgical procedure
* Planned for elective surgical procedures (e.g. hernia, orchiopexy, gastroscopy, cystoscopy)
* ASA (American Society of Anaesthesiologists) physical status classification system score 1-2 as determined by investigator
* Planned for induction of anaesthesia by an intravenous anaesthetic agent, requiring placement of peripheral venous catheter immediately prior to the surgical procedure
* Needs premedication before induction of anaesthesia as determined by investigator
* Informed consent by the legally acceptable representative(s)
* The legally acceptable representative(s) and patients 15-17 years must be able to understand and speak local language
* A female participant who has onset of menarche is eligible to participate if she is not pregnant, not breastfeeding and agree to follow the contraceptive guidance during the treatment period for at least 7 days after administration of study treatment.

Exclusion Criteria:

* Ex-premature infant (born \<37 weeks AND less than 60 weeks post conceptual age at the day of the surgical procedure)
* Mental retardation
* Abnormal nasal cavity or nasal obstruction
* Clinical contraindications to narcotic analgesia including head injury or any condition that can in the opinion of the investigator, deteriorate safety and well-being of the participants, influence PK data or optimal participation in the trial
* Medical history including substance or alcohol abuse
* Has received treatment with sufentanil and/or ketamine during the last 72 hours prior to surgery
* Has planned perioperative administration of sufentanil and/or ketamine
* Has or is suspected of having a family or personal history of malignant hyperthermia
* Has or is suspected of having allergies to ketamine or sufentanil

Primary outcomes:
measure: Total absorption over time
timeFrame: 0 - 120 minutes
measure: Maximum absorption
timeFrame: 0 - 120 minutes
measure: Distribution
timeFrame: 120 - 240 minutes
measure: Elimination
timeFrame: 120 - 240 minutes
measure: Elimination
timeFrame: 120 - 240 minutes
Secondary outcomes:
measure: Analgetic effect
timeFrame: 0 - 1 hour
measure: Sedation
timeFrame: 0 - 1 hour
measure: Feasibility, (Acceptance of intranasal administration)
timeFrame: 0- 4 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Anæstesi- og Operationsafdelingen 4013 Juliane Marie Centeret
state: Region H
Study officials:
affiliation: Department of Anaesthesiology, The Juliane Marie Centre Copenhagen University Hospital
name: Volker Classen, MD
role: PRINCIPAL_INVESTIGATOR
References: