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Avoid With locoregional Analgesia Persistant Postoperative Pain After Surgery In Children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503499-25-00
Acronym
RC23_0009
Enrollment
222
Registered
2024-02-12
Start date
2024-06-06
Completion date
Unknown
Last updated
2024-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative pain after surgery

Brief summary

Measurement of pain by a Numerical Rating Scale (NRS) 3 months after pediatric orthopedic trauma surgery

Detailed description

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.

Interventions

DRUGNALBUPHINE RENAUDIN 20 mg/2 ml
DRUGsolution injectable
DRUGsolution pour perfusion
DRUGSUFENTANIL VIATRIS 5 microgrammes/ml
DRUGsolution injectable (IV ou péridurale)
DRUGZOPHREN 4 mg/5 ml
DRUGsirop
DRUGMORPHINE (CHLORHYDRATE) LAVOISIER 10 mg/ml
DRUGTOPALGIC 100 mg/ml
DRUGCARBOCAINE 10 mg/ml
DRUGIBUPROFENE EG 200 mg
DRUGcomprimé pelliculé
DRUGKETOPROFENE MEDISOL 100 mg/4 ml
DRUGsolution à diluer pour perfusion
DRUGDOLIPRANE 150 mg
DRUGINTRALIPIDE 20 POUR CENT
DRUGémulsion pour perfusion.
DRUGSUXAMETHONIUM AGUETTANT 10 mg/mL

Sponsors

Centre Hospitalier Universitaire De Nantes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Measurement of pain by a Numerical Rating Scale (NRS) 3 months after pediatric orthopedic trauma surgery

Secondary

MeasureTime frame
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.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026