Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521075-31-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intranasal Ketamine | Active Comparator |
| |
| intranasal Sufentanil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Sufentanil | Drug | After randomization, the children will receive intranasal Sufentanil . |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. . | 30 minutes after the administration of the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | every 5 minutes for the first 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Occurrence of adverse events during follow-up, including respiratory depression, bradycardia, hypotension, and discomfort during intranasal administration. | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aline JOULIE, PHD | Contact | +33492030520 | joulie.a@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| MARCO OLLA, MD | Fondation Lenval Hôpitaux pediatrique Nice chu Lenval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital lenval | Nice | France | 06000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42161544 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intranasal Ketamine (IN) | Drug | After randomization, chidren will receive intranasal Ketamine |
|
| 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. |
| 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. | at 60 minutes |
Parental satisfaction assessed at the end of follow-up using a three-option question: satisfied, not satisfied, or no opinion. |
| 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. | 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. | 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. | 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. | 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. | 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 0 |
| Assessment of supplemental analgesic consumption: After Time 0 | Consumption of additional analgesics will be assessed as binary parameters (yes/no). | 60 minutes |
| Assessment of supplemental analgesic consumption: Category | 3 catergories will be classified:
| 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. | 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. | 60 minutes |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D000377 | Agnosia |
| D010146 | Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided