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

Phase 2

Recruiting

• Conditions: Pain

• Registration Number: NCT06364072
• Lead Sponsor: Cessatech A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-4-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Inclusion Criteria:<br><br> - Pediatric participant, age 1 year to 17 years<br><br> - Attending an Emergency Department following an injury<br><br> - Acute pain of moderate or severe intensity<br><br> - Obtained informed consent by parent/guardian and assent from the child if possible<br> and relevant (age dependent)<br><br>Exclusion Criteria:<br><br> - Participant showing abnormal nasal cavity/airway such as:<br><br> 1. major septal deviation<br><br> 2. evidence of previous nasal disease or surgery<br><br> 3. current significant nasal congestion due to common cold<br><br> - Has received treatment with sufentanil and/or ketamine during the last 72 hours<br><br> - Known or suspected allergy to ketamine or sufentanil<br><br> - Critical, life- or limb-threatening condition requiring immediate management

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability;To evaluate the analgesic effect

Secondary Outcome Measures

Name	Time	Method
To assess medication errors