Sufentanil Versus Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children. (SUF-KET-PED)

Fondation Lenval

Status and phase: Begins enrollment this month; Phase 4

Conditions: Fractures Bone; Traumatology; Pain Management; Analgesia; Acute Pain; Pain; Wounds and Injury

Treatments: Drug: Intranasal Ketamine (IN); Drug: Intranasal Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT06968546

24-HPNCL-03

2025-521075-31-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

intranasal Ketamine

Active Comparator group

Treatment:

Drug: Intranasal Ketamine (IN)

intranasal Sufentanil

Experimental group

Treatment:

Drug: Intranasal Sufentanil