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

NCT06968546 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: 24-HPNCL-032025-521075-31-00
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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. .

  30 minutes after the administration of the treatment.

Secondary Outcomes (3)

• Time to effective analgesia

  every 5 minutes for the first 30 minutes

• Excessive sedation

  every 5 minutes for the first 30 minutes

• Child-reported satisfaction with pain management

  at 60 minutes

Other Outcomes (12)

• Adverse events

  every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.

• Parental satisfaction with pain management

  at 60 minutes

• Treatment tolerance: discomfort from intranasal instillation

  every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.

Study Arms (2)

intranasal Ketamine

ACTIVE COMPARATOR

Drug: Intranasal Ketamine (IN)

intranasal Sufentanil

EXPERIMENTAL

Drug: Intranasal Sufentanil

Interventions

Intranasal Sufentanil DRUG

After randomization, the children will receive intranasal Sufentanil .

intranasal Sufentanil

Intranasal Ketamine (IN) DRUG

After randomization, chidren will receive intranasal Ketamine

intranasal Ketamine

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Obtaining written and signe informed consent from one of the two parents or legal guardians
• Affiliation with a social security system
• Hemodynamically stable
• For post-menarche girls: negative urine pregnancy test and effective contraception, in accordance with national regulations

You may not qualify if:

• 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
• History of epilepsy or known psychiatric illness
• History of respiratory, cardiac or renal insufficiency
• Use of serotonergic antidepressants
• Any child with an ongoing respiratory condition (asthma, laryngitis)
• Thoracic trauma
• Use of opioids within the 4 hours prior to arrival in the ermergency department
• Any child with an ongoing respiratory condition (asthma, laryngitis)
• Thoracic trauma
• Use of opioids within the 4 hours prior to arrival in the ermergency department
• History of head, abdominal, or spinal trauma
• Confirmed pregnancy

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hôpital lenval

Nice, France, 06000, France

Location

MeSH Terms

Conditions

Wounds and Injuries; Fractures, Bone; Agnosia; Pain; Acute Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MARCO OLLA, MD

  Fondation Lenval Hôpitaux pediatrique Nice chu Lenval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aline JOULIE, PHD

CONTACT

+33492030520; joulie.a@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 13, 2025
• Study Start: February 5, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)