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Completed

NCT Number: NCT06364072

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital General Universitario Dr. Balmis, Alicante, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • major septal deviation
  • evidence of previous nasal disease or surgery
  • 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

Treatment and study plan

CT001

Drug

Intranasal

Primary outcomes

  1. Sedation

    Time frame: 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.

    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.

  2. Respiratory Depression

    Time frame: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.

    Respiratory depression assessed by respiratory rate.

  3. Peripheral Oxygen Saturation

    Time frame: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.

    Peripheral oxygen saturation assessed by oxygen saturation rate (%)

  4. Cardiovascular Stability

    Time frame: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.

    Cardiovascular stability assessed by pulse rate (bpm)

  5. Number of Reported Adverse Events

    Time frame: Through study completion; up to 7 days

    Number of reported adverse events.

  6. Number of Adverse Events (AEs) Reported Per Participant

    Time frame: Through study completion; up to 7 days

    Number of adverse events (AEs) reported per participant.

  7. Local Nasal Irritation

    Time frame: 30 and 60 min post IMP administration

    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.

  8. Analgesic Effect

    Time frame: At baseline and at 15 and 30 min post first IMP dose

    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).

Secondary outcomes

  1. Treatment Satisfaction

    Time frame: Prior to Emergency Department discharge (day of IMP administration)

    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)).

  2. Feasibility (Acceptance of Nasal Administration)

    Time frame: Prior to Emergency Department discharge (day of IMP 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".

  3. Medication Errors

    Time frame: Assessed immediately post IMP administration

    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.

  4. Maximum Change From Baseline in Pain Intensity Within 30 Min Post (First) IMP Administration.

    Time frame: 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).

  5. Number of Participants That Achieved a 30% (or More) Reduction in Pain Intensity Relative to Baseline

    Time frame: 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).

  6. Change From Baseline in Pain Intensity

    Time frame: at 10, 15, 20, 30, 45 and 60 min post last dose of 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).

  7. Number of Children Receiving Additional Analgesics

    Time frame: During the 60 min period post last dose of IMP

    Number of children receiving additional analgesics.

Sponsors and collaborators

Lead sponsor

Cessatech A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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