Randomized Controlled Study Comparing Sufentanil and Ketamine Intranasally in the Management of Severe Acute Trauma-Related Pain in Children

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondation Lenval Nice

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

3 Feb 2026 → ongoing

Decision date (initial)

2025-09-30

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2025-521075-31-00

ClinicalTrials.gov

NCT06968546

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To compare the analgesic efficacy of intranasal sufentanil in the management of severe pain in children admitted to the pediatric emergency department with that of intranasal ketamine in the context of limb trauma.

Secondary objectives 6

1. a) Compare the time from analgesic action to achieving effective pain control.
2. b) Compare the frequency of occurrence of excessive sedation between treatment groups.
3. c) Analyze the tolerance to treatment in both groups of patients.
4. d) Compare parental satisfaction between the two groups regarding pain management during care.
5. e) Compare children's satisfaction between the two groups regarding pain management during care
6. (f) Compare the consumption of additional analgesics between treatment groups.

Conditions and MedDRA coding

SEVERE ACUTE TRAUMA-RELATED PAIN

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. - Child aged 6 to 17 years inclusive, weighing over 15 kg and requiring analgesia for the management of acute pain of traumatic origin;;
2. - Cause of pain: trauma to the limbs, excluding thoracic injuries with dyspnea and abdominal pain; including the following types of trauma: Suspected fracture (upper or lower limbs); Severe sprains and contusions; Dislocations; Other joint trauma (excluding thoracic or abdominal trauma)
3. - Severe pain, defined by a score > 6/10 on a validated scale (NRS)
4. - Hemodynamically stable.
5. - Traumatology limited to the limbs
6. - Membership in a social security system;
7. - The informed consent of both holders of parental authority must be sought as a priority for the inclusion of a minor in the study. However, in accordance with Article L.1122-2 of the Public Health Code, the signature of just one holder of parental authority is possible as an exception when the other holder cannot be contacted within a timeframe compatible with the methodological requirements of the trial regarding its purposes (management of severe acute pain in an emergency context). In any case, the investigator commits to informing the second holder of parental authority as soon as possible after the child is included in the research.
8. - Minors of childbearing age (post-menarche): Negative urine pregnancy test performed before randomization and documented in the eCRF.
9. Minors of childbearing age (post-menarche): Effective contraception in place before inclusion and accepted by the minor (pills, implant, intrauterine device, abstinence)
10. M- Minors of childbearing age (post-menarchal): Interview "contraception and pregnancy test" conducted face-to-face with the minor, without the presence of those holding parental authority, in accordance with article L1111-5 of the Public Health Code.

Exclusion criteria 21

1. - Patient in a state of vital distress from the outset ;
2. - Known hypersensitivity to opioids or ketamine ;
3. - Allergy to one of the study therapies;
4. - History of epilepsy or known psychiatric illness ;
5. - History of respiratory, cardiac, or renal failure;
6. - High blood pressure
7. - Taking serotoninergic antidepressants;
8. - Confirmed pregnancy;
9. - Nasal or sinus surgery in the 6 months preceding inclusion;
10. - Any child experiencing a respiratory condition in progress (asthma, laryngitis, tracheitis);
11. - Opioid use in the 4 hours preceding arrival at the emergency room;
12. - Having presented with a head, abdominal, thoracic or spinal trauma;
13. - Facial trauma, of the nose (CI to intra-nasal injection);
14. - Having consumed toxins.
15. - Respiratory or cardiac failure;
16. - Concurrent use of central nervous system depressant medications.
17. - Parents not understanding and/or not speaking French;
18. - Absence of effective contraception at the time of inclusion (for a minor of childbearing age);
19. - Refusal of the pregnancy test or inability to perform it before randomization;
20. Positive pregnancy test
21. - Refusal of the one-on-one interview about contraception / the test.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The effectiveness of the treatments will be assessed by evaluating pain. The intensity of pain will be measured using the vertical visual analog scale (VAS). Effectiveness will be defined as the change in pain intensity measured between the initial time (T0), when the treatment is administered, and the 30th minute (T30). Thus, we will define ∆intensity = IntensityT30 – IntensityT0.The average change in intensity will be compared between the groups.

Secondary endpoints 6

1. The analgesic action time will be defined as the measure of the elapsed time (in minutes) between the administration of the treatment and the achievement of a pain score considered effective. This score is defined as a reduction of at least 20 mm on the initial visual analog scale score (T0). Therefore, the pain will be assessed every 5 minutes for up to 30 minutes, in order to precisely determine the moment of achieving control.
2. The assessment of sedation in each treatment group will be carried out using the Ramsay scale.The degree of sedation will be evaluated every 5 minutes after the intranasal injection of the study treatment until 30 minutes, and then every 10 minutes until 60 minutes post-injection.A patient will be defined as being in excessive sedation if the score is > 3.
3. The evaluation of treatment tolerance will be carried out by collecting the number and nature of the adverse effects reported by patients in each group. The rate of occurrence of an adverse effect will be compared between the two groups to determine whether one of the treatments is associated with a higher frequency of this adverse effect.
4. The evaluation of parent satisfaction will be carried out by a closed question asked at the end of the intervention, at 60 minutes: "Are you satisfied with your child's pain management?", possible answers: "Satisfied", "Not satisfied", "No opinion".
5. Children's satisfaction will be assessed using a Likert-type questionnaire with a smiley scale before the age of 10, and after the age of 10, a validated PREM (Patient Reported Experience Measure) questionnaire of 25 questions, specifically adapted for pediatric emergencies. Either of the questionnaires will be offered 60 minutes after the end of care, for immediate feedback, without disrupting the care process.
6. The consumption of additional analgesics will be evaluated in the form of binary parameters (yes/no). It will be clearly distinguished whether this consumption occurred before or after T0. Three distinct categories (Level I, Level II, MEOPA) and the reasons justifying the administration of additional analgesics will be documented. The time before the administration of an additional analgesic will be collected and analyzed.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondation Lenval Nice

Sponsor organisation

Fondation Lenval Nice

Address

57 Avenue De La Californie

City

Nice

Postcode

06200

Country

France

Scientific contact point

Organisation

Fondation Lenval Nice

Contact name

Dr Olla Marco

Public contact point

Organisation

Fondation Lenval Nice

Contact name

JOULIE Aline

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications