Intranasal pain relief for children in emergency care
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
This study is testing a nasal spray for pain relief in kids aged 1 to 17 who are in emergency care to see how well it works and if it's safe for them.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | Cessatech A/S Industry-sponsored |
| Locations | 7 sites (Alicante and 6 other locations) |
| Trial ID | NCT06364072 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety, tolerability, and analgesic efficacy of an intranasal formulation of sufentanil and ketamine (CT001) in pediatric patients experiencing acute pain in emergency settings. It aims to assess how well this treatment works and its feasibility for use in children aged 1 to 17 years. Participants will be evaluated for their pain levels and any side effects following administration of the nasal spray. The study is part of a broader clinical development plan for CT001 as a pain management option for children.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 1 to 17 years who are experiencing moderate to severe acute pain due to an injury and are attending an emergency department.
Not a fit: Patients with significant nasal congestion, previous nasal surgery, or critical conditions requiring immediate intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide effective pain relief for children in emergency situations with fewer side effects compared to traditional methods.
How similar studies have performed: While this approach is novel in the pediatric emergency context, similar intranasal analgesic methods have shown promise in adult populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Alicante and 6 other locations
- Hospital General Universitario Dr. Balmis — Alicante, Spain (Recruiting)
- Hospital Sant Joan de Deu — Barcelona, Spain (Recruiting)
- Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP) - — Madrid, Spain (Recruiting)
- Complejo Hospitalario Universitario de Santiago (CHUS) — Santiago De Compostela, Spain (Recruiting)
- Birmingham Women's and Children's NHS Foundation Trust — Birmingham, United Kingdom (Recruiting)
- Royal London Hospital — London, United Kingdom (Recruiting)
- Sheffield Children's Hospital — Sheffield, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Stuart Hartshorn, Dr. — Birmingham Children's Hospital
- Study coordinator: Malene C Christensen
- Email: malene.cording@cessatech.com
- Phone: +45 61715350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.