Efficiency of IV dexamethasone compared to placebo, administrated after a lower limb blockade is done, on the post operative pain in children : a controled, randomised, double blind study.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2018
INTERVENTION: Trade Name: DEXAMETHASONE MYLAN Product Name: DEXAMETHASONE MYLAN Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: post operative pain ; MedDRA version: 20.0 Level: LLT Classification code 10002182 Term: Analgesia System Organ Class: 100000004865 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: Evaluate the efficiency of 0,2mg/kg IV dexamathasone administrated at anesthesia induction compared to placebo, on the decrease of post operative pain in children from 6 to 15 who are qualified for a lower limb surgery with a loco‐regional anesthesia Primary end point(s): Morphinic consumption in the post operative 24H Secondary Objective: ‐ Evaluate the efficiency of 0,2mg/kg IV dexamathasone administrated at anesthesia induction compared to placebo, on the increase of the delay of first post operative morphinic consumption in children from 6 to 15 who are qualified for a lower limb surgery with a loco‐regional anesthesia.; ‐ Evaluate that 0,2mg/kg IV dexamathasone administrated at anesthesia induction compared to placebo, doesn't increase the lower limb motor blokade duration in children from 6 to 15 who are qualified for a lower limb surgery with a loco‐regional anesthesia; ‐ Evaluate the efficiency of 0,2mg/kg IV dexamathasone administrated at anesthesia induction compared to placebo, on the decrease of post operative nausea and vomiting in children from 6 to 15 who are qualified for a lower limb surgery with a loco‐regional anesthesia Timepoint(s) of evaluation of this end point: during the post operative 24h SECONDARY OUTCOME: Secondary end point(s): ‐ delay between the realisation of the lower limb blockade ans the first ‐; consumption of morphinic; ‐ duration the the motor blockade; ‐ prevalence of post opérative nausea/vomiting Timepoint(s) of evaluation of this end point: during the post operative 24h; during the post operative 24h; during the post operative 24h 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
Epistemonikos ID: 3818524569b7dfd90a4412bacd0eda6cc3d56081
First added on: Aug 24, 2024