Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
222
Countries
1
Sites
1
Post-operative pain after surgery
To show the positive impact of locoregional Analgesia in the prevention of persistant postoperative Pain after orthopedic trauma surgery in children
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 6 Jun 2024 → ongoing
- Decision date (initial)
- 2024-02-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Fondation APICIL · CHU Nantes - Appel d'offre interne
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To show the positive impact of locoregional Analgesia in the prevention of persistant postoperative Pain after orthopedic trauma surgery in children
Secondary objectives 7
- Compare neuropathic pain in the two randomization arms
- Compare immediate post-operative pain in the ICU
- Compare the persistence over time of this chronic post-surgical pain, if it exists.
- Compare the incidence of postoperative nausea and vomiting in the ICU
- Compare monitoring times in the ICU
- Compare opioid consumption during hospitalization.
- Compare intravenous morphine consumption in the ICU
Conditions and MedDRA coding
Post-operative pain after surgery
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10002325 | Anesthesia local | 10042613 |
| 20.1 | LLT | 10054711 | Postoperative pain | 10022117 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Period There is only one period during which patients will be randomised between 2 arms
|
Randomised Controlled | None | Experimental: Locoregional Analgesia + general anaesthesia Controle: General anaesthesia alone |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Age ≥ 5 years and < 15 years and 3 month
- Indication for surgical treatment of a fracture by osteosynthesis
- Patient affiliated to the social security system
- Informed and signed consent of patient and one of the two holders of parental authority
- Conscious patient (Glasgow score =15)
- Patient can give a verbal assessment of their pain
Exclusion criteria 10
- Refusal to participate by one of the two holders of parental authority or by the child
- Sensory neurological deficit of the operated limb on preoperative examination
- Ischemia of the operated limb on preoperative examination
- Polytrauma patient
- Known allergy to Mepivacaine
- Patient included in a category 1 interventional clinical trial of analgesic therapy
- Patient on anticoagulant drugs
- Epilepsy not controlled by a treatment
- Porphyria
- atrioventricular conduction disorders
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Measurement of pain by a Numerical Rating Scale (NRS) 3 months after pediatric orthopedic trauma surgery
Secondary endpoints 7
- 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
- The dose of intravenous opiates received intraoperatively, the dose of intravenous opiates titrated in the Post-Interventional Monitoring Room and the dose of opiates received in the hospital ward during the first 24 hours postoperatively.
- The dose of IV morphine received in the ICU.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
CARBOCAINE 10 mg/ml, solution injectable
PRD4875485 · Product
- Active substance
- Mepivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB — AMIDES
- Marketing authorisation
- 34009 341 693 6 6
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 14
NALBUPHINE RENAUDIN 20 mg/2 ml, solution injectable
PRD2935573 · Product
- Active substance
- Nalbuphine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 0.2 mg/kg milligram(s)/kilogram
- Max total dose
- 0.2 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AF02 — NALBUFINE
- Marketing authorisation
- 34009 358 314 3 9
- MA holder
- LABORATOIRE RENAUDIN
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PARACETAMOL B BRAUN 10 mg/ml, solution pour perfusion
PRD2387334 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 15 mg/Kg milligram(s)/kilogram
- Max total dose
- 15 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- 34009 583 081 2 3
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SEVOFLURANE BAXTER 1 ml/ml, liquide pour inhalation par vapeur
PRD316591 · Product
- Active substance
- Sevoflurane
- Pharmaceutical form
- INHALATION VAPOUR, LIQUID
- Route of administration
- INHALATION
- Max daily dose
- 7 % percent
- Max total dose
- 7 % percent
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AB08 — SEVOFLURANE
- Marketing authorisation
- 34009 567 477 2 6
- MA holder
- BAXTER SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUFENTANIL VIATRIS 5 microgrammes/ml, solution injectable (IV ou péridurale)
PRD9497435 · Product
- Active substance
- Sufentanil
- Substance synonyms
- OX27
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS SLOW BOLUS INJECTION
- Max daily dose
- 5 pg picogram(s)
- Max total dose
- 5 pg picogram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH03 — SUFENTANIL
- Marketing authorisation
- NL 28399
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10107981 · Product
- Active substance
- Ondansetron Hydrochloride
- Substance synonyms
- ONDANSETRON HCL
- Pharmaceutical form
- SYRUP
- Route of administration
- ORAL USE
- Max daily dose
- 0.15 mg/kg milligram(s)/kilogram
- Max total dose
- 0.15 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A04AA01 — ONDANSETRON
- Marketing authorisation
- 34009 341 656 3 4
- MA holder
- SANDOZ
- MA country
- France
- Paediatric formulation
- Yes
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MORPHINE (CHLORHYDRATE) LAVOISIER 10 mg/ml, solution injectable
PRD498943 · Product
- Active substance
- Morphine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 0.1 mg/kg milligram(s)/kilogram
- Max total dose
- 0.1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- 34009 340 213 0 5
- MA holder
- LABORATOIRES CHAIX ET DU MARAIS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
TOPALGIC 100 mg/ml, solution buvable
PRD426375 · Product
- Active substance
- Tramadol Hydrochloride
- Substance synonyms
- TRAMADOL HCL, (±)-TRANS-2-DIMETHYLAMINOMETHYL-1-(3-METHOXYPHENYL)CYCLOHEXANOL HYDROCHLORIDE
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 2 mg/kg milligram(s)/kilogram
- Max total dose
- 2 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AX02 — TRAMADOL
- Marketing authorisation
- 34009 362 067 7 9
- MA holder
- SANOFI-AVENTIS FRANCE
- MA country
- France
- Paediatric formulation
- Yes
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PROPOFOL LIPURO 1 % (10 mg/ml), émulsion injectable ou pour perfusion
PRD4511825 · Product
- Active substance
- Propofol
- Substance synonyms
- 2,6-Bis(PROPAN-2-YL)PHENOL, DISOPROFOL, 2,6-DIPROPAN-2-YLPHENOL
- Pharmaceutical form
- EMULSION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 5 mg/Kg milligram(s)/kilogram
- Max total dose
- 5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX10 — PROPOFOL
- Marketing authorisation
- 34009 571 735 2 4
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DEXAMETHASONE VIATRIS 4 mg/1 ml, solution injectable en ampoule
PRD9743868 · Product
- Active substance
- Dexamethasone Phosphate
- Substance synonyms
- DEXAMETHASONE 21-(DIHYDROGEN PHOSPHATE)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0.15 mg/kg milligram(s)/kilogram
- Max total dose
- 0.15 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- NL17722
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IBUPROFENE EG 200 mg, comprimé pelliculé
PRD514390 · Product
- Active substance
- Ibuprofen
- Substance synonyms
- (RS)-2-(4-isobutylphenyl)propionic acid, 2-(4-isobutylphenyl)propionic acid
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02B — OTHER ANALGESICS AND ANTIPYRETICS
- Marketing authorisation
- NL29535
- MA holder
- EG LABO LABORATOIRES EUROGENERICS - DO NOT USE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KETOPROFENE MEDISOL 100 mg/4 ml, solution à diluer pour perfusion
PRD5609735 · Product
- Active substance
- Ketoprofen
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 1 mg/Kg milligram(s)/kilogram
- Max total dose
- 1 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AE03 — KETOPROFEN
- Marketing authorisation
- NL42621
- MA holder
- MEDISOL
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DOLIPRANE 150 mg, poudre pour solution buvable en sachet-dose
PRD430927 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 15 mg/kg milligram(s)/kilogram
- Max total dose
- 15 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- 34009 349 986 2 1
- MA holder
- OPELLA HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- Yes
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
INTRALIPIDE 20 POUR CENT, émulsion pour perfusion.
PRD3259420 · Product
- Active substance
- Soya Oil, Purified
- Substance synonyms
- PURIFIED SOYA-BEAN OIL
- Pharmaceutical form
- EMULSION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 3 millilitre(s)/kilogram
- Max total dose
- 3 millilitre(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BA02 — FAT EMULSIONS
- Marketing authorisation
- 34009 355 096 5 9
- MA holder
- FRESENIUS KABI FRANCE S.A.S.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUXAMETHONIUM AGUETTANT 10 mg/mL, solution injectable en seringue préremplie
PRD7522194 · Product
- Active substance
- Suxamethonium Chloride Dihydrate
- Substance synonyms
- Succinylcholine chloride dihydrate, Succinylcholine dichloride dihydrate, Suxamethonium dichloride dihydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 1 mg/Kg milligram(s)/kilogram
- Max total dose
- 1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AB01 — SUXAMETHONIUM
- Marketing authorisation
- 34009 301 880 4 0
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 1 Place Alexis Ricordeau
- City
- Nantes
- Postcode
- 44000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Dr Rémi Bernardon
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Dr Rémi Bernardon
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 222 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-06-06 | 2024-06-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-503499-25-00 | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 10-15y | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 5-10y | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF parent | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Chlorydrate de mepivacaine | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503499-25-00 | 2.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-21 | France | Acceptable 2024-01-30
|
2024-02-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-26 | France | Acceptable 2024-10-11
|
2024-10-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-02 | France | Acceptable 2026-02-19
|
2026-03-12 |