NCT06968546

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

Randomized Controlled Study Comparing Sufentanil and Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Fondation Lenval · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Traumatology
• Wounds and Injury
• Fractures Bone
• Analgesia
• Pain
• Pain Management
• Acute Pain

Interventions

Type	Name	Description
DRUG	Intranasal Sufentanil	After randomization, the children will receive intranasal Sufentanil .
DRUG	Intranasal Ketamine (IN)	After randomization, chidren will receive intranasal Ketamine

Timeline

• Start date: 2026-02-05
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2025-05-13
• Last updated: 2026-01-28

Locations

1 site across 1 country: France