asal spray (CT001) as pain medication before anesthesia in planned surgical procedures - A study of pharmacokinetics in children and adolescents aged 1-17 years

Phase 1

• Conditions: Management of acute pain in children 1-17 years with the objective of preventing pain and distress associated with painful medical procedures in children.; MedDRA version: 20.0Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2021-000137-14-DK
• Lead Sponsor: Cessatech A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-15
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

i.Paediatric participants, age 1-17 years at the day of the surgical procedure
ii.Planned for elective surgical procedures (e.g. hernia, orchiopexy, gastroscopy, cystoscopy)
iii.ASA (American Society of Anaesthesiologists) physical status classification system score 1-2 as determined by investigator
iv.Planned for induction of anaesthesia by an intravenous anaesthetic agent, requiring placement of peripheral venous catheter immediately prior to the surgical procedure
v.Needs premedication before induction of anaesthesia as determined by investigator
vi.Informed consent by the legally acceptable representative(s)
vii.The legally acceptable representative(s) and patients 15-17 years must be able to understand and speak local language
viii.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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

i.)Ex-premature infant (born <37 weeks AND less than 60 weeks post conceptual age at the day of the surgical procedure)
ii.)Mental retardation
iii.)Abnormal nasal cavity or nasal obstruction
iv.)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
v.)Medical history including substance or alcohol abuse
vi.)Has received treatment with sufentanil and/or ketamine during the last 72 hours prior to surgery
vii.)Has planned perioperative administration of sufentanil and/or ketamine
viii.)Has or is suspected of having a family or personal history of malignant hyperthermia
ix.)Has or is suspected of having allergies to ketamine or sufentanil
x.)Female participants who have a positive urine pregnancy test within 24 hours before the first dose of study treatment. If the urine test cannot be confirmed negative by a blood pregnancy test, the participant must be excluded from participation in the trial
xi.)Positive Covid-19 test (within the last 14 days) or clinical suspicion of Covid-19 (according to current local guidelines)
xii.)Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent/assent for this current trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified