BridgeMD
RANDOMIZED CONTROLLED STUDY COMPARING SUFENTANIL AND KETAMINE INTRANASALLY IN THE MANAGEMENT OF SEVERE ACUTE TRAUMA-RELATED PAIN IN CHILDREN
EU CTIS ID: 2025-521075-31-00
What this study is testing
To compare the analgesic efficacy of intranasal sufentanil in the management of severe pain in children admitted to the pediatric emergency department with that of intranasal ketamine in the context of limb trauma.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Child aged 6 to 17 years inclusive, weighing over 15 kg and requiring analgesia for the management of acute pain of traumatic origin;;
- M- Minors of childbearing age (post-menarchal): Interview "contraception and pregnancy test" conducted face-to-face with the minor, without the presence of those holding parental authority, in accordance with article L1111-5 of the Public Health Code.
- - Cause of pain: trauma to the limbs, excluding thoracic injuries with dyspnea and abdominal pain; including the following types of trauma: Suspected fracture (upper or lower limbs); Severe sprains and contusions; Dislocations; Other joint trauma (excluding thoracic or abdominal trauma)
- - Severe pain, defined by a score > 6/10 on a validated scale (NRS)
- - Hemodynamically stable.
- - Traumatology limited to the limbs
You likely can't join if
- - Patient in a state of vital distress from the outset ;
- - Any child experiencing a respiratory condition in progress (asthma, laryngitis, tracheitis);
- - Opioid use in the 4 hours preceding arrival at the emergency room;
- - Having presented with a head, abdominal, thoracic or spinal trauma;
- - Facial trauma, of the nose (CI to intra-nasal injection);
- - Having consumed toxins.
See the full eligibility criteria
- - Child aged 6 to 17 years inclusive, weighing over 15 kg and requiring analgesia for the management of acute pain of traumatic origin;;
- M- Minors of childbearing age (post-menarchal): Interview "contraception and pregnancy test" conducted face-to-face with the minor, without the presence of those holding parental authority, in accordance with article L1111-5 of the Public Health Code.
- - Cause of pain: trauma to the limbs, excluding thoracic injuries with dyspnea and abdominal pain; including the following types of trauma: Suspected fracture (upper or lower limbs); Severe sprains and contusions; Dislocations; Other joint trauma (excluding thoracic or abdominal trauma)
- - Severe pain, defined by a score > 6/10 on a validated scale (NRS)
- - Hemodynamically stable.
- - Traumatology limited to the limbs
- - Membership in a social security system;
- - The informed consent of both holders of parental authority must be sought as a priority for the inclusion of a minor in the study. However, in accordance with Article L.1122-2 of the Public Health Code, the signature of just one holder of parental authority is possible as an exception when the other holder cannot be contacted within a timeframe compatible with the methodological requirements of the trial regarding its purposes (management of severe acute pain in an emergency context). In any case, the investigator commits to informing the second holder of parental authority as soon as possible after the child is included in the research.
- - Minors of childbearing age (post-menarche): Negative urine pregnancy test performed before randomization and documented in the eCRF.
- Minors of childbearing age (post-menarche): Effective contraception in place before inclusion and accepted by the minor (pills, implant, intrauterine device, abstinence)
- - Patient in a state of vital distress from the outset ;
- - Any child experiencing a respiratory condition in progress (asthma, laryngitis, tracheitis);
- - Opioid use in the 4 hours preceding arrival at the emergency room;
- - Having presented with a head, abdominal, thoracic or spinal trauma;
- - Facial trauma, of the nose (CI to intra-nasal injection);
- - Having consumed toxins.
- - Respiratory or cardiac failure;
- - Concurrent use of central nervous system depressant medications.
- - Parents not understanding and/or not speaking French;
- - Absence of effective contraception at the time of inclusion (for a minor of childbearing age);
- - Refusal of the pregnancy test or inability to perform it before randomization;
- - Known hypersensitivity to opioids or ketamine ;
- Positive pregnancy test
- - Refusal of the one-on-one interview about contraception / the test.
- - Allergy to one of the study therapies;
- - History of epilepsy or known psychiatric illness ;
- - History of respiratory, cardiac, or renal failure;
- - High blood pressure
- - Taking serotoninergic antidepressants;
- - Confirmed pregnancy;
- - Nasal or sinus surgery in the 6 months preceding inclusion;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.