sufentanil citrate for Severe acute trauma-related pain

Inclusion criteria

• {"criterion_text":"- Child aged 6 to 17 years inclusive, weighing over 15 kg and requiring analgesia for the management of acute pain of traumatic origin;;\n- 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.\n- 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)\n- Severe pain, defined by a score > 6/10 on a validated scale (NRS)\n- Hemodynamically stable.\n- Traumatology limited to the limbs\n- Membership in a social security system;\n- 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.\n- Minors of childbearing age (post-menarche): Negative urine pregnancy test performed before randomization and documented in the eCRF.\n- Minors of childbearing age (post-menarche): Effective contraception in place before inclusion and accepted by the minor (pills, implant, intrauterine device, abstinence)"}

Exclusion criteria

• {"criterion_text":"- Patient in a state of vital distress from the outset ;\n- Any child experiencing a respiratory condition in progress (asthma, laryngitis, tracheitis);\n- Opioid use in the 4 hours preceding arrival at the emergency room;\n- Having presented with a head, abdominal, thoracic or spinal trauma;\n- Facial trauma, of the nose (CI to intra-nasal injection);\n- Having consumed toxins.\n- Respiratory or cardiac failure;\n- Concurrent use of central nervous system depressant medications.\n- Parents not understanding and/or not speaking French;\n- Absence of effective contraception at the time of inclusion (for a minor of childbearing age);\n- Refusal of the pregnancy test or inability to perform it before randomization;\n- Positive pregnancy test\n- Refusal of the one-on-one interview about contraception / the test.\n- Known hypersensitivity to opioids or ketamine ;\n- Allergy to one of the study therapies;\n- History of epilepsy or known psychiatric illness ;\n- History of respiratory, cardiac, or renal failure;\n- High blood pressure\n- Taking serotoninergic antidepressants;\n- Confirmed pregnancy;\n- Nasal or sinus surgery in the 6 months preceding inclusion;"}

Primary endpoints

• {"endpoint_text":"- The effectiveness of the treatments will be assessed by evaluating pain. The intensity of pain will be measured using the vertical visual analog scale (VAS). Effectiveness will be defined as the change in pain intensity measured between the initial time (T0), when the treatment is administered, and the 30th minute (T30). Thus, we will define ∆intensity = IntensityT30 – IntensityT0.The average change in intensity will be compared between the groups.","definition_or_measurement_approach":"Pain intensity measured using the vertical visual analog scale (VAS). Effectiveness = change in pain intensity between T0 (treatment administration) and T30; ∆intensity = IntensityT30 – IntensityT0. The average change will be compared between groups."}

Secondary endpoints

• {"endpoint_text":"- The analgesic action time will be defined as the measure of the elapsed time (in minutes) between the administration of the treatment and the achievement of a pain score considered effective. This score is defined as a reduction of at least 20 mm on the initial visual analog scale score (T0). Therefore, the pain will be assessed every 5 minutes for up to 30 minutes, in order to precisely determine the moment of achieving control.","definition_or_measurement_approach":"Time (minutes) from treatment administration to achievement of effective pain control defined as ≥20 mm reduction on the initial VAS (T0). Pain assessed every 5 minutes up to 30 minutes."}
• {"endpoint_text":"- The assessment of sedation in each treatment group will be carried out using the Ramsay scale.The degree of sedation will be evaluated every 5 minutes after the intranasal injection of the study treatment until 30 minutes, and then every 10 minutes until 60 minutes post-injection.A patient will be defined as being in excessive sedation if the score is > 3.","definition_or_measurement_approach":"Sedation assessed by the Ramsay scale every 5 minutes up to 30 minutes, then every 10 minutes until 60 minutes. Excessive sedation defined as Ramsay score > 3."}
• {"endpoint_text":"- The evaluation of treatment tolerance will be carried out by collecting the number and nature of the adverse effects reported by patients in each group. The rate of occurrence of an adverse effect will be compared between the two groups to determine whether one of the treatments is associated with a higher frequency of this adverse effect.","definition_or_measurement_approach":"Tolerance assessed by number and nature of adverse events reported; rates of occurrence compared between groups."}
• {"endpoint_text":"- The evaluation of parent satisfaction will be carried out by a closed question asked at the end of the intervention, at 60 minutes: \"Are you satisfied with your child's pain management?\", possible answers: \"Satisfied\", \"Not satisfied\", \"No opinion\".","definition_or_measurement_approach":"Single closed question at 60 minutes post-intervention with responses: 'Satisfied', 'Not satisfied', 'No opinion'."}
• {"endpoint_text":"- Children's satisfaction will be assessed using a Likert-type questionnaire with a smiley scale before the age of 10, and after the age of 10, a validated PREM (Patient Reported Experience Measure) questionnaire of 25 questions, specifically adapted for pediatric emergencies. Either of the questionnaires will be offered 60 minutes after the end of care, for immediate feedback, without disrupting the care process.","definition_or_measurement_approach":"Children <10: Likert-type smiley scale; children ≥10: 25-question PREM; administered 60 minutes after end of care."}
• {"endpoint_text":"- The consumption of additional analgesics will be evaluated in the form of binary parameters (yes/no). It will be clearly distinguished whether this consumption occurred before or after T0. Three distinct categories (Level I, Level II, MEOPA) and the reasons justifying the administration of additional analgesics will be documented. The time before the administration of an additional analgesic will be collected and analyzed.","definition_or_measurement_approach":"Additional analgesic consumption recorded as yes/no, categorized by timing (before/after T0), analgesic level (Level I, Level II, MEOPA), reasons for administration, and time to administration."}

France

Earliest CTIS Part Ii Submission Date

11-09-2025

Latest Decision Or Authorization Date

30-09-2025

Processing Time Days

19

Number Of Sites

1

Number Of Participants

116

Primary sponsor

Full Name

Fondation Lenval Nice

Organisation Type

Patient organisation/association

Country Of Registered Address

France