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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: CT001

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT001	Drug: CT001; Intranasal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation	Sedation was assessed by sedation score on the University of Michigan Sedation Scale (UMSS). Scores range from 0 to 4, where 0 = awake/alert, 1 = minimally sedated (tired/sleepy, appropriate response to verbal conversation and/or sound), 2 = moderately sedated (somnolent/sleeping, easily aroused with light tactile stimulation or simple verbal command), 3 = deeply sedated (deep sleep, arousable only with significant physical stimulation), and 4 = unarousable. Lower scores indicate less sedation; higher scores indicate deeper sedation.	At baseline and 10, 15, 20, 30, 45 and 60 min after first IMP administration. If a second IMP dose was needed, sedation score was performed at the timepoints relative to first IMP administration.
Respiratory Depression	Respiratory depression assessed by respiratory rate.	At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Peripheral Oxygen Saturation	Peripheral oxygen saturation assessed by oxygen saturation rate (%)	At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Cardiovascular Stability	Cardiovascular stability assessed by pulse rate (bpm)	At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Number of Reported Adverse Events	Number of reported adverse events.	Through study completion; up to 7 days
Number of Adverse Events (AEs) Reported Per Participant	Number of adverse events (AEs) reported per participant.	Through study completion; up to 7 days
Local Nasal Irritation	The number of participants with nasal irritation was summarised using counts of participants for each timepoint (30 and 60 min post IMP administration) by type of nasal irritation.	30 and 60 min post IMP administration
Analgesic Effect	Number and proportion of participants that respond to the treatment relative to baseline (i.e. reduction in pain score to 4 or below). Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable).	At baseline and at 15 and 30 min post first IMP dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Satisfaction	Treatment satisfaction as assessed by responses to the question: "How satisfied are you with the study drug that you/your child received? Please think about how it helped their pain, how it was given, any side effects, and how quickly you/your child recovered". Respondents answered using a 5-point Likert scale (very unsatisfied (1), unsatisfied (2), neutral (3), satisfied (4), very satisfied (5)).	Prior to Emergency Department discharge (day of IMP administration)
Feasibility (Acceptance of Nasal Administration)	Feasibility (i.e. acceptance of nasal administration) was addressed by the healthcare staff asking the participant: "If you were in this situation again and needed pain medication, would you like to receive the nasal spray (relative to an injection, tablet or suppository for the pain)?' If not possible by the participant, the parent/legal guardian assessed nasal acceptability. Answers were "yes, "no", "I don't know".	Prior to Emergency Department discharge (day of IMP administration)
Medication Errors	Medication errors, defined as any deviation in the IMP administration instructions that resulted in higher or lower dose than planned. Examples may include erroneous priming of the pump, too few/many pumps administered, etc.	Assessed immediately post IMP administration
Maximum Change From Baseline in Pain Intensity Within 30 Min Post (First) IMP Administration.	Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable).	30 min post (first) IMP administration
Number of Participants That Achieved a 30% (or More) Reduction in Pain Intensity Relative to Baseline	Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable).	within 30 min post (first) IMP administration.
Change From Baseline in Pain Intensity	Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable).	at 10, 15, 20, 30, 45 and 60 min post last dose of IMP administration.
Number of Children Receiving Additional Analgesics	Number of children receiving additional analgesics.	During the 60 min period post last dose of IMP

Collaborators and Investigators

• Sponsor: Cessatech A/S
• Investigators: Principal Investigator: Stuart Hartshorn, Dr., Birmingham Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Actual): May 9, 2025
• Study Completion (Actual): May 9, 2025

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: PDC 01-0202; 2023-504023-63-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No