Intranasal sufentanil versus ketamine for acute severe traumatic pain in children: protocol for a phase II randomised controlled trial (SUF-KET-PED)
Abstract
Introduction: 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.
Methods and analysis: 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.
Ethics and dissemination: The study was…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 116 participants or records.
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