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: 20.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Sponsors
Cessatech A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: • To determine the PK profile of CT001 in children 1-2 years undergoing surgical procedures. • To collect supplemental PK data in children >2-17 years. ;Secondary Objective: Secondary objectives: • Acceptance of intranasal administration. • Assessment of pain related to placement of a peripheral venous catheter for induction of anaesthesia. • Assessment of sedation. • Safety including adverse events and vital signs ;Primary end point(s): Pharmacokinetics: • Non-compartmental PK parameters: AUC (0-120 min), Cmax, Tmax, T½, Clearance (CL/F), Volume of distribution (V/F). • Compartmental PK parameters: clearance, volume and absorption rate constant parameters associated with the data-driven compartmental models required to describe the obtained data. ;Timepoint(s) of evaluation of this end point: PK samples at the time points 10±5 min, 20±5 min, 30±5 min, 60±10 min, 90±15 min, and 120±15 min post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Analgesic effect: • Assessment of pain intensity by age-appropriate scale in relation to the placement of peripheral venous catheter: For age group = 1 year to < 5 years Face, legs, cry, consolability (FLACC) score (0 = no pain, 10 = worst pain). For age group = 5 years to < 8 years visual analogue scale modified with Wong-Baker faces and for age group = 8 years Numerical Rating Scale (0 = no pain, 10 = worst pain). Sedation: • Assessment of sedation at the time of placement of the peripheral venous catheter using the University of Michigan Sedation Score (UMSS). Feasibility: • Acceptance of intranasal administration: Acceptance of the intranasal route of administration by the child (yes, no, do not know) assessed by the child, if not possible, by legally acceptable representative(s) and health care professional. Safety variables: • The number and proportion (%) of participants with AEs • Vital signs including heart rate, blood oxygen saturation level, mean arterial pressure, respiratory rate, and ECG. ;Timepoint(s) of evaluation of this end point: Analgesic and sedation effect: up to approximately 1 hour post dosing. Assessment of safety approximately 24 hours post dosing. | — |
Countries
Denmark
Contacts
Public ContactCEO
Cessatech A/S
Outcome results
None listed