TraumatologyPhase 2SUF-KET-PEDNCT06968546
Sufentanil Versus Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.
A Phase 2 study testing Intranasal Sufentanil and Intranasal Ketamine (IN) in people with Traumatology and Wounds and Injury, run by Fondation Lenval at 1 site in France.
Trial summary
Pain is one of the most common reasons for children to attend emergency departments, particularly following traumatic injuries such as fractures, sprains, or contusions. Despite advances in medical care, severe acute pain in children is still sometimes inadequately treated. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Traumatology, Wounds and Injury, Fractures Bone
- What is being tested?
- Intranasal Sufentanil and Intranasal Ketamine (IN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2026to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 to 17 years inclusive, under 18 years old, weighing more than 10kg, and requiring analgesia for the management of acute pain
- Presenting with pain assessed as severe using a validated pain scale (VAS > 6/10)
- Acute traumatic lime injury
- Pain caused by trauma, excluding thoracic trauma with dyspnea and abdominal pain
- Obtaining written and signe informed consent from one of the two parents or legal guardians
- Affiliation with a social security system
- Hemodynamically stable
- For post-menarche girls: negative urine pregnancy test and effective contraception, in accordance with national regulations
Who cannot join
- Patient in a state of immediate life-threatening distress
- Parents who don't understand and/or don't speak French
- Known hypersensitivity to opiods
- Allergy to one of the study treatments
- History of epilepsy or known psychiatric illness
- History of respiratory, cardiac or renal insufficiency
Show all 18Show fewer
- Use of serotonergic antidepressants
- Any child with an ongoing respiratory condition (asthma, laryngitis)
- Thoracic trauma
- Use of opioids within the 4 hours prior to arrival in the ermergency department
- Any child with an ongoing respiratory condition (asthma, laryngitis)
- Thoracic trauma
- Use of opioids within the 4 hours prior to arrival in the ermergency department
- History of head, abdominal, or spinal trauma
- Confirmed pregnancy
- History of toxic substance use
- Facial or nasal trauma
- Whithdrawal of informed consent from the parents or legal guardian
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital lenval
Nice, France, 06000
Marco OLLA, MD, +33 4-92-03-04-29, marco.olla@hpu.lenval.com
About this study
Official title: Randomized Controlled Study Comparing Sufentanil and Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.
Pain is one of the most common reasons for children to attend emergency departments, particularly following traumatic injuries such as fractures, sprains, or contusions. Despite advances in medical care, severe acute pain in children is still sometimes inadequately treated. One important reason is that intravenous pain medication can be technically difficult, stressful, or delayed in paediatric patients.
Intranasal drug administration, which involves spraying medication into the nose, offers a rapid and needle-free way to relieve pain and is increasingly used in paediatric emergency care. Two medications can be administered through this route: ketamine and sufentanil. Intranasal ketamine is already widely used in children for pain management. Sufentanil is a potent opioid analgesic commonly used in adults and in anaesthesia but has been much less studied in children when administered intranasally.
Read more
The aim of this study is to compare the effectiveness and safety of intranasal sufentanil and intranasal ketamine in children aged 6 to 17 years who present to the emergency department with severe traumatic limb pain. Both medications will be given in addition to standard care, including the routine use of an oxygen-nitrous oxide gas mixture (MEOPA), which is commonly used to reduce pain and anxiety in children.
Children who take part in the study will be randomly assigned to receive either intranasal sufentanil or intranasal ketamine. Pain levels will be assessed at regular time points after medication administration using age-appropriate pain scales. Sedation level and possible side effects will also be closely monitored for a short period following treatment.
The hypothesis of this study is that intranasal sufentanil will provide greater pain relief than intranasal ketamine 30 minutes after administration, without increasing the risk of adverse effects, when both are used alongside standard emergency care.
The results of this study are expected to improve knowledge about fast, effective, and non-invasive pain relief strategies for children in emergency settings and may help optimise future pain management protocols in paediatric emergency care.
- Conditions
- Traumatology, Wounds and Injury, Fractures Bone, Analgesia, Pain, Pain Management
- Being tested
- Intranasal Sufentanil, Intranasal Ketamine (IN)
- Medical subject headings
- Wounds and Injuries, Fractures, Bone, Agnosia, Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal SufentanilDrug
After randomization, the children will receive intranasal Sufentanil .
Intranasal Ketamine (IN)Drug
After randomization, chidren will receive intranasal Ketamine
| Study group | Role | What they receive |
|---|---|---|
| intranasal Ketamine | Active comparator | Not described Receives: Drug: Intranasal Ketamine (IN) |
| intranasal Sufentanil | Experimental | Not described Receives: Drug: Intranasal Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity from baseline to 30 minutes after intranasal administration
Pain intensity will be measured using a validated 100-mm Visual Analogue Scale (VAS) appropriate for children aged 6 years and older. The baseline pain score (T0) will be recorded immediately before intranasal administration of the study medication. .
Measured: 30 minutes after the administration of the treatment.
Secondary outcomes (3)
Time to effective analgesia
Time in minutes from intranasal drug administration to the first reduction of at least 20 mm on the Visual Analogue Scale (VAS). Pain is assessed every 5 minutes up to 30 minutes. Observations are censored if rescue analgesia is required.
Measured: every 5 minutes for the first 30 minutes
Excessive sedation
Sedation assessed using the Ramsay Sedation Scale. Excessive sedation is defined as a Ramsay score greater than 3 at any time during follow-up.
Measured: every 5 minutes for the first 30 minutes
Child-reported satisfaction with pain management
Child-reported satisfaction assessed using a smiley-face scale for children under 10 years and a validated PREM questionnaire for children aged 10 years and older.
Measured: at 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start5 Feb 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumatologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARCO OLLA, MD, Principal investigator, Fondation Lenval Hôpitaux pediatrique Nice chu Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968546
- Sponsor's protocol ID
- 24-HPNCL-03
- Other IDs
- 2025-521075-31-00, 2025
- Acronym
- SUF-KET-PED
- Status last verified
- Jan 2026
- First submitted
- 24 Apr 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendes Dos Reis C, Olla M, Freyssinet E, Baranton E, Joulie A, Fontas E, Tran A. Intranasal sufentanil versus ketamine for acute severe traumatic pain in children: protocol for a phase II randomised controlled trial (SUF-KET-PED). BMJ Open. 2026 May 20;16(5):e112617. doi: 10.1136/bmjopen-2025-112617.
PubMed 42161544
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Comparing Sufentanil and Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.
- ClinicalTrials.gov ID
- NCT06968546
- Acronym / sponsor ID
- SUF-KET-PED / 24-HPNCL-03
- Conditions
- Traumatology, Wounds and Injury, Fractures Bone, Analgesia, Pain, Pain Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 5 Feb 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain is one of the most common reasons for children to attend emergency departments, particularly following traumatic injuries such as fractures, sprains, or contusions. Despite advances in medical care, severe acute pain in children is still sometimes inadequately treated. One important reason is that intravenous pain medication can be technically difficult, stressful, or delayed in paediatric patients.
Intranasal drug administration, which involves spraying medication into the nose, offers a rapid and needle-free way to relieve pain and is increasingly used in paediatric emergency care. Two medications can be administered through this route: ketamine and sufentanil. Intranasal ketamine is already widely used in children for pain management. Sufentanil is a potent opioid analgesic commonly used in adults and in anaesthesia but has been much less studied in children when administered intranasally.
The aim of this study is to compare the effectiveness and safety of intranasal sufentanil and intranasal ketamine in children aged 6 to 17 years who present to the emergency department with severe traumatic limb pain. Both medications will be given in addition to standard care, including the routine use of an oxygen-nitrous oxide gas mixture (MEOPA), which is commonly used to reduce pain and anxiety in children.
Children who take part in the study will be randomly assigned to receive either intranasal sufentanil or intranasal ketamine. Pain levels will be assessed at regular time points after medication administration using age-appropriate pain scales. Sedation level and possible side effects will also be closely monitored for a short period following treatment.
The hypothesis of this study is that intranasal sufentanil will provide greater pain relief than intranasal ketamine 30 minutes after administration, without increasing the risk of adverse effects, when both are used alongside standard emergency care.
The results of this study are expected to improve knowledge about fast, effective, and non-invasive pain relief strategies for children in emergency settings and may help optimise future pain management protocols in paediatric emergency care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intranasal Ketamine | Active comparator | Drug: Intranasal Ketamine (IN) |
| intranasal Sufentanil | Experimental | Drug: Intranasal Sufentanil |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged 6 to 17 years inclusive, under 18 years old, weighing more than 10kg, and requiring analgesia for the management of acute pain
- Presenting with pain assessed as severe using a validated pain scale (VAS > 6/10)
- Acute traumatic lime injury
- Pain caused by trauma, excluding thoracic trauma with dyspnea and abdominal pain
- Obtaining written and signe informed consent from one of the two parents or legal guardians
Key exclusion criteria (18 listed)
- Patient in a state of immediate life-threatening distress
- Parents who don't understand and/or don't speak French
- Known hypersensitivity to opiods
- Allergy to one of the study treatments
- History of epilepsy or known psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal SufentanilAfter randomization, the children will receive intranasal Sufentanil . | Drug | intranasal Sufentanil |
| Intranasal Ketamine (IN)After randomization, chidren will receive intranasal Ketamine | Drug | intranasal Ketamine |
Primary outcome
Change in pain intensity from baseline to 30 minutes after intranasal administration
Time frame: 30 minutes after the administration of the treatment.
Pain intensity will be measured using a validated 100-mm Visual Analogue Scale (VAS) appropriate for children aged 6 years and older. The baseline pain score (T0) will be recorded immediately before intranasal administration of the study medication. .
3 secondary outcomes
Time to effective analgesia
Time frame: every 5 minutes for the first 30 minutes
Excessive sedation
Time frame: every 5 minutes for the first 30 minutes
Child-reported satisfaction with pain management
Time frame: at 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Derived from this study: PubMed 42161544Mendes Dos Reis C, Olla M, Freyssinet E, Baranton E, Joulie A, Fontas E, Tran A. Intranasal sufentanil versus ketamine for acute severe traumatic pain in children: protocol for a phase II randomised controlled trial (SUF-KET-PED). BMJ Open. 2026 May 20;16(5):e112617. doi: 10.1136/bmjopen-2025-112617.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MARCO OLLA, MD principal investigator
Fondation Lenval Hôpitaux pediatrique Nice chu Lenval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal Sufentanil and Intranasal Ketamine (IN) in people with Traumatology and Wounds and Injury, run by Fondation Lenval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aline JOULIE, PHD (+33492030520, joulie.a@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity from baseline to 30 minutes after intranasal administration (time frame: 30 minutes after the administration of the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06968546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.