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

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. - DEXPED

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000314-38-FR

Enrollment

Registered

2018-06-07

Start date

2018-09-11

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

post operative pain MedDRA version: 20.0 Level: LLT Classification code 10002182 Term: Analgesia System Organ Class: 100000004865

Interventions

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 pl

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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;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;Primary end point(s): Morphinic consumption in the post operative 24H;Timepoint(s) of evaluation of this end point: during the post operative 24h	—

Measure

Time frame

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;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;Primary end point(s): Morphinic consumption in the post operative 24H;Timepoint(s) of evaluation of this end point: during the post operative 24h

—

Secondary

Measure	Time frame
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	—

Countries

France

Contacts

Public ContactDirection Recherche et Innovation

CHRU de Nancy

rechclin-innov@chru-nancy.fr3338315 5285

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026