Sufentanil Versus Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-17
SponsorFondation Lenval
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Acute traumatic lime injury
Pain caused by trauma, excluding thoracic trauma with dyspnea and abdominal pain
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intranasal Sufentanil
DrugAfter randomization, the children will receive intranasal Sufentanil .
Intranasal Ketamine (IN)
DrugAfter randomization, chidren will receive intranasal Ketamine
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: intranasal KetamineActive comparator 1 intervention
Group B: intranasal SufentanilExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain intensity from baseline to 30 minutes after intranasal administration
Pain intensity will be measured using a validated 100-mm Visual Analogue Scale (VAS) appropriate for children aged 6 years and older. The baseline pain score (T0) will be recorded immediately before intranasal administration of the study medication. .
Time frame
30 minutes after the administration of the treatment.Secondary outcomes
1
Time to effective analgesia
Time in minutes from intranasal drug administration to the first reduction of at least 20 mm on the Visual Analogue Scale (VAS). Pain is assessed every 5 minutes up to 30 minutes. Observations are censored if rescue analgesia is required.
Time frame
every 5 minutes for the first 30 minutes2
Excessive sedation
Sedation assessed using the Ramsay Sedation Scale. Excessive sedation is defined as a Ramsay score greater than 3 at any time during follow-up.
Time frame
every 5 minutes for the first 30 minutes3
Child-reported satisfaction with pain management
Child-reported satisfaction assessed using a smiley-face scale for children under 10 years and a validated PREM questionnaire for children aged 10 years and older.
Time frame
at 60 minutesOther outcomes
1
Adverse events
Occurrence of adverse events during follow-up, including respiratory depression, bradycardia, hypotension, and discomfort during intranasal administration.
Time frame
every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.2
Parental satisfaction with pain management
Parental satisfaction assessed at the end of follow-up using a three-option question: satisfied, not satisfied, or no opinion.
Time frame
at 60 minutes3
Treatment tolerance: discomfort from intranasal instillation
Monitoring for potential adverse events such as discomfort from intranasal instillation. For each adverse effect, the rate of patients experiencing at least one occurrence will be calculated, the severity will be graded, and the need for additional intervention will be documented.
Time frame
every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.4
Treatment tolerance: Bradycardia
Monitoring for potential adverse events such as bradycardia. For each adverse effect, the rate of patients experiencing at least one occurrence will be calculated, the severity will be graded, and the need for additional intervention will be documented.
Time frame
every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.Sponsors and contacts
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Source ClinicalTrials.gov
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