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

Open-label, Prospective Study to Assess the Safety, Tolerability, Analgesic Effect and Feasibility of Intranasal Sufentanil/Ketamine in Pediatric Patients With Moderate or Severe Pain, in an Acute Care Setting

The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children.

Inclusion Criteria:

• Pediatric participant, age 1 year to 17 years
• Attending an Emergency Department following an injury
• Acute pain of moderate or severe intensity
• Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent)

Exclusion Criteria:

• Participant showing abnormal nasal cavity/airway such as:

  1. major septal deviation
  2. evidence of previous nasal disease or surgery
  3. current significant nasal congestion due to common cold

• Has received treatment with sufentanil and/or ketamine during the last 72 hours

• Known or suspected allergy to ketamine or sufentanil

• Critical, life- or limb-threatening condition requiring immediate management