SYF6fc870a3dcc84bf09012b747a714029cRegistry ID: 2023-503499-25-00|RecruitingPhase 4
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interventional
N/A
1 country
1
To show the positive impact of locoregional Analgesia in the prevention of persistant postoperative Pain after orthopedic trauma surgery in children
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 21, 2023
Actual (reported)Measurement of pain by a Numerical Rating Scale (NRS) 3 months after pediatric orthopedic trauma surgery
Response score to DN4 neuropathic pain screening questionnaire ≥4/10 at 3, 6 and 12 months.
1st EN score for immediate post-operative care in the Post-Interventional Monitoring Room
Presence of pain assessed by numerical scale >3/10 at 6 and 12 months post-surgery
The number of patients experiencing at least one episode of nausea and one episode of vomiting in the Post-Interventional Monitoring Room.
Duration in minutes of monitoring in the Post-Interventional Monitoring Room
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
PARACETAMOL B BRAUN 10 mg/ml, solution pour perfusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
KETOPROFENE MEDISOL 100 mg/4 ml, solution à diluer pour perfusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
CARBOCAINE 10 mg/ml, solution injectable
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
SUFENTANIL VIATRIS 5 microgrammes/ml, solution injectable (IV ou péridurale)
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
PARACETAMOL B BRAUN 10 mg/ml, solution pour perfusion
Named ingredient: Paracetamol
View registry recordKETOPROFENE MEDISOL 100 mg/4 ml, solution à diluer pour perfusion
Named ingredient: Ketoprofen
View registry recordCARBOCAINE 10 mg/ml, solution injectable
Named ingredient: Mepivacaine hydrochloride
View registry recordSUFENTANIL VIATRIS 5 microgrammes/ml, solution injectable (IV ou péridurale)
Named ingredient: Sufentanil
View registry recordIBUPROFENE EG 200 mg, comprimé pelliculé
Named ingredient: Ibuprofen
View registry recordDOLIPRANE 150 mg, poudre pour solution buvable en sachet-dose
Named ingredient: Paracetamol
View registry recordTOPALGIC 100 mg/ml, solution buvable
Centre Hospitalier Universitaire De Nantes
Nantes, 44000, France
Dr Rémi Bernardon
First Submitted
November 21, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Formulated product
IBUPROFENE EG 200 mg, comprimé pelliculé
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
Formulated product
DOLIPRANE 150 mg, poudre pour solution buvable en sachet-dose
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORAL SOLUTION
View registry recordFormulated product
TOPALGIC 100 mg/ml, solution buvable
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORAL SOLUTION
View registry recordFormulated product
PROPOFOL LIPURO 1 % (10 mg/ml), émulsion injectable ou pour perfusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
EMULSION FOR INJECTION/INFUSION
View registry recordNamed ingredient: Tramadol hydrochloride
PROPOFOL LIPURO 1 % (10 mg/ml), émulsion injectable ou pour perfusion
Named ingredient: Propofol
View registry recordContact the study team to confirm eligibility.