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.
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.
Single-group open-label intranasal CT001 (sufentanil + ketamine) in paediatric acute pain.
Intranasal sufentanil + ketamine formulation (CT001); single-group treatment in ED setting; dose not specified in registry fragment.