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

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 possibleand 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