Intranasal sufentanil versus ketamine for acute severe traumatic pain in children: protocol for a phase II randomised controlled trial (SUF-KET-PED).

Abstract

Effective management of severe pain in children presenting to emergency departments remains challenging. Intravenous analgesia is often delayed due to technical and emotional difficulties related to vascular access. Intranasal administration offers a rapid, needle-free route. Although ketamine is widely used intranasally for paediatric analgesia, sufentanil may represent a potent alternative with favourable pharmacological properties. However, comparative paediatric data are lacking. SUF-KET-PED is a single-centre, randomised controlled superiority trial conducted in the paediatric emergency department of Lenval Children's Hospital, Nice, France. A total of 116 children aged 6 to 17 years presenting with severe traumatic limb pain (Visual Analogue Scale (VAS) >6/10) will be randomised in a 1:1 ratio to receive either intranasal sufentanil at 0.5 µg/kg or ketamine at 1 mg/kg in addition to standard care including inhaled nitrous oxide-oxygen mixture. Pain will be assessed using the VAS at baseline and at predefined intervals up to 30 min. Sedation will be monitored using the Ramsay Sedation Scale and adverse events will be recorded throughout a 60-minute follow-up period.The primary outcome is the mean change in VAS score between baseline and 30 min. Secondary outcomes include time to effective analgesia, excessive sedation, adverse events, use of rescue analgesia and patient and parent satisfaction. The study was approved by the French Ethics Committee CPP Sud Méditerranée V and authorised by the French National Agency for Medicines and Health Products Safety, IDRCB no 2025-521075-31-00. Results will be disseminated through publication in peer-reviewed journals and presentation at scientific conferences. EU Clinical Trials Information System: 2025-521075-31-00. gov: NCT06968546.