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

Cessatech

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Pain

Treatments

Drug: CT001

Study type

Interventional

Funder types

Industry

Identifiers

NCT06364072

2023-504023-63-00

PDC 01-0202

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

1 to 17 years old

Volunteers

No Healthy Volunteers

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