Sufentanil Versus Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.

• Status: NOT_YET_RECRUITING
• Trial end date: 2028-03-31

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.

• Phase: PHASE4

Details

• Lead Sponsor: Fondation Lenval