Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT04897750
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
17 Years
Study:
NCT04897750
Study Brief:
Protocol Section:
NCT04897750