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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04897750
• Other study ID #: PDC 01-0206
• Status: Completed
• Phase: Phase 2
• Start date: August 19, 2021
• Est. completion date: May 16, 2022

Study information

• Verified date: April 2022
• Source: Cessatech A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
Denmark	Anæstesi- og Operationsafdelingen 4013 Juliane Marie Centeret	Copenhagen	Region H

Sponsors (1)

Lead Sponsor	Collaborator
Cessatech A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total absorption over time	Area under the concentration vs time curve	0 - 120 minutes
Primary	Maximum absorption	Peak concentration (Cmax)	0 - 120 minutes
Primary	Distribution	Volumen of distribution (Vd)	120 - 240 minutes
Primary	Elimination	Half life (T½)	120 - 240 minutes
Primary	Elimination	Clearance,	120 - 240 minutes
Secondary	Analgetic effect	pain intensity by age-appropriate scale in relation to the placement of peripheral venous catheter	0 - 1 hour
Secondary	Sedation	Assessment of sedation at the time of placement of the peripheral venous catheter using the University of Michigan Sedation Score	0 - 1 hour
Secondary	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