A Phase 2 interventional study of Intranasal Sufentanil and Intranasal Ketamine (IN) in Traumatology, Wounds and Injury and Fractures Bone, sponsored by Fondation Lenval. Not yet recruiting at 1 site in France. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Fondation Lenval · Phase 2, Interventional, and Treatment
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.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 116 is above the median of 80 across 458 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Fondation Lenval is the lead sponsor of 61 studies on the registry; 18 are open to participants now.
Compared within Fractures, Bone, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Wounds and Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Intranasal Ketamine (IN)
Drug: Intranasal Sufentanil
After randomization, the children will receive intranasal Sufentanil .
After randomization, chidren will receive intranasal Ketamine
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. .
Time frame: 30 minutes after the administration of the treatment.
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.
Time frame: 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.
Time frame: 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.
Time frame: at 60 minutes
Adverse events
Occurrence of adverse events during follow-up, including respiratory depression, bradycardia, hypotension, and discomfort during intranasal administration.
Time frame: every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.
Parental satisfaction with pain management
Parental satisfaction assessed at the end of follow-up using a three-option question: satisfied, not satisfied, or no opinion.
Time frame: at 60 minutes
Treatment tolerance: discomfort from intranasal instillation
Monitoring for potential adverse events such as discomfort from intranasal instillation. For each adverse effect, the rate of patients experiencing at least one occurrence will be calculated, the severity will be graded, and the need for additional intervention will be documented.
Time frame: every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.
Treatment tolerance: Bradycardia
Monitoring for potential adverse events such as bradycardia. For each adverse effect, the rate of patients experiencing at least one occurrence will be calculated, the severity will be graded, and the need for additional intervention will be documented.
Time frame: every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.
Treatment tolerance: Desaturation
Monitoring for potential adverse events such as desaturation. For each adverse effect, the rate of patients experiencing at least one occurrence will be calculated, the severity will be graded, and the need for additional intervention will be documented.
Time frame: every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.
Treatment tolerance: Bradypnea
3 - Monitoring for potential adverse events such as bradypnea. For each adverse effect, the rate of patients experiencing at least one occurrence will be calculated, the severity will be graded, and the need for additional intervention will be documented.
Time frame: every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.
Treatment tolerance: sedation
Monitoring for potential adverse events such as sedation. For each adverse effect, the rate of patients experiencing at least one occurrence will be calculated, the severity will be graded, and the need for additional intervention will be documented.
Time frame: every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.
Assessment of supplemental analgesic consumption: Before Time 0
Consumption of additional analgesics will be assessed as binary parameters (yes/no).
Time frame: Time 0
Assessment of supplemental analgesic consumption: After Time 0
Consumption of additional analgesics will be assessed as binary parameters (yes/no).
Time frame: 60 minutes
Assessment of supplemental analgesic consumption: Category
3 catergories will be classified: * Level I (e.g., paracetamol, ibuprofen) * Level II (e.g., profenid) * MEOPA (equimolar mixture of oxygen and nitrous oxide)
Time frame: 60 minutes
Assessment of supplemental analgesic consumption: Administrative reason
The reasons for administering additional analgesics (e.g., persistent pain, child's request, clinical assessment, immobilization) will be documented.
Time frame: 60 minutes
Deadline of supplemental analgesic consumption
The time to administration of additional analgesic, defined as the time in minutes between administration of the primary treatment (T0) and the first dose of additional analgesic, will be collected and analyzed.
Time frame: 60 minutes
Plan to share: No
Start is estimated for Feb 2026; primary completion for Mar 2028, 25 months later.
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Studies of the drug tested here: Sufentanil
Fondation Lenval