Phase 3
N=155
Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients
Pain
Bottom Line
View on ClinicalTrials.gov: NCT06364072 ↗Enrolled (actual)
155
Serious AEs
2.6%
Results posted
Feb 2026
Primary outcome: Primary: Sedation — 0; 0; 1; 1 UMSS score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CT001 (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Cessatech A/S
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sedation |
0; 0; 1; 1; 1; 0 | — |
| PRIMARY Respiratory Depression |
26; 24; 24; 23; 21; 22 | — |
| PRIMARY Peripheral Oxygen Saturation |
98; 98; 98; 98; 97; 98 | — |
| PRIMARY Cardiovascular Stability |
117; 108; 111; 109; 118; 109 | — |
| PRIMARY Number of Reported Adverse Events |
132 | — |
| PRIMARY Number of Adverse Events (AEs) Reported Per Participant |
0.85 | — |
| PRIMARY Local Nasal Irritation |
16; 7; 0; 1; 3; 1 | — |
| PRIMARY Analgesic Effect |
82; 70; 134; 18 | — |
| SECONDARY Treatment Satisfaction |
5 | — |
| SECONDARY Feasibility (Acceptance of Nasal Administration) |
143; 4; 6 | — |
| SECONDARY Medication Errors |
3; 152 | — |
| SECONDARY Maximum Change From Baseline in Pain Intensity Within 30 Min Post (First) IMP Administration. |
-6 | — |
| SECONDARY Number of Participants That Achieved a 30% (or More) Reduction in Pain Intensity Relative to Baseline |
145 | — |
| SECONDARY Change From Baseline in Pain Intensity |
-2; -4; -5; -4; -6; -6 | — |
| SECONDARY Number of Children Receiving Additional Analgesics |
17 | — |
Summary
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.
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:
- 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
Data sourced from ClinicalTrials.gov (NCT06364072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.