Efficiency of IV Dexamethasone, Administered After a Lower Limb Blockade, on the Post Operative Pain in Children

NCT03618173 | Unknown Phase 3 DMC

• 1 other identifier: 2018-000314-38
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Intravenous dexamethasone (IV) can be used alone in adults as an adjunct to peri-nerves blocks, for diffusion blocks. In pediatrics, dexamethasone is used daily according to the assessment of the anesthetist, by extension of the recommendations of the adult, as adjuvant in perinervous blocks although no study has been published yet concerning his interest. However, the physiology of the child is not superimposable to that of the adult (renal function, volume of distribution, plasma protein binding ...). We thus wish to study the effectiveness of the administration of IV dexamethasone at the time of anesthetic induction in the prolongation of the duration of the block of the lower limbs in the child and its repercussion on the postoperative consumption of morphine. Main Objective : Evaluate the efficiency, compared to placebo, of IV dexamethasone at the dose of 0.2 mg / kg administered as a bolus at the time of anesthetic induction, on the early postoperative pain (first 24 hours) in the child of 6 to 15 years undergoing surgery that requires the achievement of a peri-neural block of the lower limb after general anesthesia Secondary objectives :

• 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 Principal endpoint :
• Morphinic consumption in the post operative 24H Secondary endpoints :
• 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

Conditions

IV Drug Usage

Keywords

dexamethasone; analgesia; lower limb blockade; children; pediatric

Outcome Measures

Primary Outcomes (1)

• Morphinic consumption in the post operative 24H

  total morphinic consumption in morphine equivalent in mg

  within 24 hours after dexamethasone or saline serum administration

Secondary Outcomes (3)

• Delay between the realisation of the lower limb blockade ans the first - consumption of morphinic

  within 24 hours after dexamethasone or saline serum administration

• Duration the the motor blockade

  within 24 hours after dexamethasone or saline serum administration

• Prevalence of post opérative nausea/vomiting

  within 24 hours after dexamethasone or saline serum administration

Study Arms (2)

dexamethasone

EXPERIMENTAL

IV dexamethasone group : dexamethasone administrated at the induction of general anesthesia, at the dose of 0,2mg/kg (= 0,2mL/kg of a syringe with a 1mg/mL concentration) maximum 8mg (=8mL).

Drug: Dexamethasone

Placebos

PLACEBO COMPARATOR

IV placebo group : saline serum is administrated at the induction of general anesthesia, at the dose of 0,2mL/kg, maximum 8mL.

Drug: Placebos

Interventions

Dexamethasone DRUG

IV dexamethasone at the dose of 0,2mg/kg = 0,2mL/kg of a solution of 1mg/mL max 8mg

Also known as: IV dexamethasone

dexamethasone

Placebos DRUG

IV saline serum at the dose of 0,2mL/kg maximum 8mL

Also known as: IV saline serum

Placebos

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant patient
• Peri-nerval catheter
• Children who are privated from their liberty because of a court or administrative decision or need psychiatric care
• Uncontrolled psychotic state
• Pregnant patients

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (1)

• Vautrin N, Thilly N, Bernard Y, Wurtz F, Meistelman C. Protocol of DEXPED trial: efficacy of intravenous dexamethasone, administered at the time of analgesic blocking of the lower limb, on postoperative pain in children: a randomised, placebo-controlled, double-blind trial. BMJ Open. 2020 Sep 30;10(9):e036863. doi: 10.1136/bmjopen-2020-036863.

  PMID: 32998920 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Claude Meistelman

  University Professor in CHRU Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas VAUTRIN

CONTACT

0676430560; nicolas_vautrin@hotmail.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 7, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 7, 2018

Record last verified: 2018-07