Open-label, prospective study to assess the safety, tolerability, analgesic effect and feasibility of IN SUF/KET in pediatric patients with moderate or severe pain, in an acute care setting

Phase 1

Recruiting

• Conditions: Pain; MedDRA version: 20.0Level: PTClassification code: 10033371Term: Pain Class: 100000004867; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: CTIS2023-504023-63-00
• Lead Sponsor: Cessatech A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-10
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Pediatric participant, age 1 year to 17 years., Attending an Emergency Department (ED) following an injury., Acute pain of moderate or severe intensity (corresponding to 5 or above on an age-appropriate pain scale (0-10 NRS, Wong-Baker FACES scale and FLACC pain scale), Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent)

Exclusion Criteria

Critical, life- or limb-threatening condition requiring immediate management., Known pregnancy or breastfeeding females., Acute intoxication with drugs or alcohol, based on the judgement of the attending physician., Abnormal nasal cavity or nasal obstruction., Known or suspected allergy to ketamine or sufentanil., Has received treatment with sufentanil and/or ketamine during the last 72 hours., Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device in the 4 weeks prior to signing the informed consent/assent for this trial., Previous enrolment in the present study., Open fractures., Participants with chronic pain., Participants requiring oxygen therapy., Clinically evident respiratory depression., Clinically evident cardiovascular instability (e.g. pathological arrhythmia)., Known liver damage., Known significant renal impairment., Presence of other acute clinical or medical condition that may, in the opinion of the investigator, put the potential subject at risk when participating in the study, impact the participant’s ability to participate in the study, or have impact on the study results, including being subject to head injury and / or altered consciousness.

Study & Design

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