MORPHINE SULFATE for Limb injuries | Traumatic pain

Inclusion criteria

• {"criterion_text":"- 1)\tChild aged 2 years to 17 years and 11 months\n- 2)\tWith 10 kg ≤ Weight ≤ 100 kg\n- 3)\tPresenting to ED with a traumatic pain and suspected fracture(s) based on an acute deformity AND experiencing pain and / or functional impotence in the injured limb(s)\n- 4)\tWithin the first 12 hours after the injury\n- 5)\tVAS pain score at ED arrival ≥ 60/100 (if child ≥ 7) or Evendol pain score at ED arrival ≥ 7/15 (if child <7 years)\n- 6)\tAffiliated to health insurance\n- 7)\tAt least one signed parental informed consent"}

Exclusion criteria

• {"criterion_text":"- Received narcotic pain medication prior to arrival\n- Contraindication to fentanyl or ketamine, mentioned in SmPC\n- GCS <15\n- Evidence of significant femur, head, chest, abdominal, or spine injury\n- Open fracture\n- Nasal trauma or complete nasal obstruction\n- Active epistaxis\n- Nasal or sinus surgery within 6 months before inclusion\n- History of high blood pressure, known coronary artery disease, congestive heart failure, acute glaucoma, increased intracranial pressure, , hepatocellular insufficiency\n- Active or history of psychiatric disorder\n- Known pregnancy or suspicion of being pregnant\n- Breastfeeding\n- Non-French speaking parent and / or child.\n- Participation to another interventional clinical research\n- Contraindication to morphine, mentioned in SmPC\n- Hypersensitivity to ketamine or fentanyl or to excipients (sodium chloride, sodium hydroxide), or to other opioids."}

Primary endpoints

• {"endpoint_text":"- Success: children <7 years with a pain score assessed by Evendol < 5 or children ≥ 7 years with pain score assessed by VAS ≤ 30, 30 minutes after drugs administration, without rescue analgesia -Failure: Evendol ≥ 5 or VAS > 30, 30 minutes after drugs administration or need for rescue analgesia during the first 30 minutes after drugs administration","definition_or_measurement_approach":"Success defined as Evendol < 5 for children <7 years or VAS ≤ 30 for children ≥7 years at 30 minutes after drug administration without receipt of rescue analgesia. Failure defined as Evendol ≥5 or VAS >30 at 30 minutes or need for rescue analgesia within first 30 minutes."}

Secondary endpoints

• {"endpoint_text":"- Success pain evaluation (success as defined in primary outcome) during the first 2 hours after drugs administration, at 15 (M15), 60 (M60), 90 (M90) and 120 minutes (M120)","definition_or_measurement_approach":"Assessment of primary outcome definition (Evendol/VAS thresholds) at M15, M60, M90 and M120 during first 2 hours after drug administration."}
• {"endpoint_text":"- Reduction in pain scores from baseline at M15, M30, M60, M90 and M120","definition_or_measurement_approach":"Change from baseline pain scores measured at specified timepoints (M15, M30, M60, M90, M120)."}
• {"endpoint_text":"- Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) at 5, 10, 15, 30, 60, 90 and 120 minutes after drugs administration.","definition_or_measurement_approach":"UMSS recorded at 5, 10, 15, 30, 60, 90, 120 minutes post-administration to assess sedation level."}
• {"endpoint_text":"- Adverse events potentially associated with IN ketamine, IN fentanyl and/or oral morphine: drowsiness, dizziness, pruritus, nausea, vomiting, dysphoria, nasal burning and irritation, unpleasant taste, vision changes, throat irritation, headache, vital sign changes (heart rate, respiratory rate, oxygen saturation, blood pressure).","definition_or_measurement_approach":"Recording of specified adverse events and changes in vital signs following administration of study treatments."}
• {"endpoint_text":"- General satisfaction of parents and patient ≥ 7 years old on a scale of 0–100 with corresponding faces (0 = no satisfaction at all, 100 = very satisfied) at ED discharge","definition_or_measurement_approach":"Parent and patient (≥7 years) satisfaction measured on 0–100 scale at ED discharge."}

France

Earliest CTIS Part Ii Submission Date

17-04-2024

Latest Decision Or Authorization Date

26-11-2025

Processing Time Days

588

Number Of Sites

8

Number Of Participants

300

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"DGOS _ ministère de la santé _ PHRC","duties_or_roles":"Source of monetary support","organisation_type":""}