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Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients

Not yet recruitingRegisteredCTG

This open-label, prospective trial (n=150) will investigate the safety, tolerability, analgesic effect, and feasibility of intranasal sufentanil/ketamine (CT001) in paediatric patients with moderate or severe pain attending an acute care setting, such as an emergency department following an injury.

Details

Open-label, single-group Phase II/III study evaluating intranasal CT001 (sufentanil plus ketamine) for acute moderate-to-severe pain in children aged 1–17 presenting to emergency departments.

Primary outcomes are safety and tolerability; secondary outcomes include analgesic efficacy and feasibility of intranasal administration in the acute care setting. Multiple sites in Spain and the United Kingdom participate.

Topics:Chronic Pain

Registry

Registry linkNCT06364072