Clinical TrialChronic PainCompleted

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

This open-label, prospective trial (n=150) will investigate the safety, tolerability, analgesic effect, and feasibility of intranasal sufentanil/ketamine (CT001) in paediatric patients with moderate or severe pain attending an acute care setting, such as an emergency department following an injury.

Target Enrollment
155 participants
Study Type
Phase II/III interventional
Design
Non-randomized

Detailed Description

Open-label, single-group Phase II/III study evaluating intranasal CT001 (sufentanil plus ketamine) for acute moderate-to-severe pain in children aged 1–17 presenting to emergency departments.

Primary outcomes are safety and tolerability; secondary outcomes include analgesic efficacy and feasibility of intranasal administration in the acute care setting. Multiple sites in Spain and the United Kingdom participate.

Study Arms & Interventions

CT001

experimental

Single-group open-label intranasal CT001 (sufentanil + ketamine) in paediatric acute pain.

Interventions

  • Compound
    via Other

    Intranasal sufentanil + ketamine formulation (CT001); single-group treatment in ED setting; dose not specified in registry fragment.

Participants

Ages
1 – 17
Sexes
Male & Female

Inclusion 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

  • 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 Details

  • Status
    Completed
  • Phase
    Phase IIPhase III
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment155 participants
  • Timeline
    Start: 2024-04-15
    End: 2024-09-20
  • Topic
    Chronic Pain

Locations

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

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