CompletedPhase 2Other

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

Sponsored by Cessatech A/S

NCT ID
NCT06364072
Target Enrollment
155 participants
Start Date
2024-05-27
Est. Completion
2025-05-09

About This Study

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.

Conditions Studied

Pain

Interventions

  • CT001

Eligibility

Age:1 Year - 17 Years
Healthy Volunteers:No
View full eligibility 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

Study Locations (7)

Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Sant Joan de Deu
Barcelona, Spain
Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP) -
Madrid, Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, Spain
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom
Royal London Hospital
London, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source