Clinical trial NCT06968546: Sufentanil Versus Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.
Official title: Randomized Controlled Study Comparing Sufentanil and Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Traumatology
Wounds and Injury
Fractures Bone
Analgesia
Pain
Pain Management
Acute Pain
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare two treatments for managing severe pain in children who have suffered trauma and are treated in pediatric emergency departments. Specifically, it evaluates intranasal sufentanil (the experimental treatment) versus intranasal ketamine (the reference treatment). The study hypothesizes that sufentanil will be non-inferior to ketamine in terms of pain relief, with a goal of reducing the pain score by at least two points on the visual analog scale (VAS) which ranges from 0 to 10.

The study design is a randomized controlled trial involving 100 children, with 50 in each treatment group. Children will be randomized upon their arrival in the emergency department, and both groups will be followed for one hour to monitor the effects. The primary outcome is effectiveness of pain control, with secondary objectives including the comparison of the time it takes for each treatment to take effect, the frequency of excessive sedation (measured using the Ramsay scale), the tolerance of each treatment, the satisfaction of the parents, and the need for additional analgesics.

This study is important because pain management in pediatric trauma cases is crucial, and there is a need for safe and effective treatments that are easy to admnister. By exploring the effectiveness and safety of sufentanil compared to ketamine, this research may provide valuable insights into pain management options for children in emergency settings.


Eligibility criteria: Inclusion Criteria:

* 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)
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Effective pain control
timeFrame: 30 minutes after the administration of the treatment.
Secondary outcomes:
measure: Time to onset of analgesic effect
timeFrame: every 5 minutes for the first 30 minutes
measure: Time to onset of analgesic effect (after 30 minutes)
timeFrame: every 10 minutes, after the 30 minutes until 1 hours
Other outcomes:
measure: Incidence of excessive sedation (first 30 minutes)
timeFrame: every 5 minutes for the first 30 minutes
measure: Incidence of excessive sedation (after 30 minutes)
timeFrame: After 30 minutes of the study treatment administration, every 10 minutes until 60 minutes
measure: Treatment tolerance: discomfort from intranasal instillation
timeFrame: every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.
measure: Treatment tolerance: Bradycardia
timeFrame: every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.
measure: Treatment tolerance: Desaturation
timeFrame: every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.
measure: Treatment tolerance: Bradypnea
timeFrame: every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.
measure: Parental satisfaction
timeFrame: at 60 minutes
measure: Treatment tolerance: sedation
timeFrame: every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.
measure: Assessment of supplemental analgesic consumption: Before Time 0
timeFrame: Time 0
measure: Assessment of supplemental analgesic consumption: After Time 0
timeFrame: 60 minutes
measure: Assessment of supplemental analgesic consumption: Category
timeFrame: 60 minutes
measure: Assessment of supplemental analgesic consumption: Administrative reason
timeFrame: 60 minutes
measure: Deadline of supplemental analgesic consumption
timeFrame: 60 minutes
Locations:
city: Nice
country: France
facility: Hôpital lenval
Study officials:
affiliation: Fondation Lenval Hôpitaux pediatrique Nice chu Lenval
name: MARCO OLLA, MD
role: PRINCIPAL_INVESTIGATOR
References: