Efficiency of dexamethasone, administrated just before the lower limb nerve blockade, on the decrease of post operative pain in childre

Phase 1

• Conditions: post operative pain; MedDRA version: 20.0Level: LLTClassification code 10002182Term: AnalgesiaSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-000314-38-FR
• Lead Sponsor: CHRU de NANCY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-07
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- Children from 6 to 15 who are qualified for a lower limb surgery with a loco-regional anesthesia with an anesthesic consultation between 90 to 2 days before the surgery
- legal guardian agreement
- Children who are affiliated to the social security
- Information of minor subjects adapted to their ability to understand
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Children who presents a contraindication to the single shot IV dexamethasone
- septic surgery
- diabetes
- corticoid treatment in the 7 days before the surgery
- outpatient surgery
- handicapped or impaired children
- pei-nerval catheter
- Children who are privated from their liberty because of a court or administrative decision or need psychiatric care
- uncontrolled psychotic state

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified