Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures

NCT ID: NCT04897750

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-19
• Study Completion Date: 2022-05-16

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.

Conditions

Analgesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active

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.

Group Type: EXPERIMENTAL

CT001

Intervention Type: 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.

Interventions

CT001

Sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg as nasal spray, followed by an additional dose 10 -15 minutes after, if needed.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cessatech A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Volker Classen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, The Juliane Marie Centre Copenhagen University Hospital

Locations

Anæstesi- og Operationsafdelingen 4013 Juliane Marie Centeret

Copenhagen, Region H, Denmark

Countries

Denmark

Other Identifiers

PDC 01-0206

Identifier Type: -

Identifier Source: org_study_id