Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03618173
Recruitment Status : Unknown
Verified July 2018 by Central Hospital, Nancy, France.
Recruitment status was:  Not yet recruiting
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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

Condition or disease Intervention/treatment Phase
IV Drug Usage Drug: Dexamethasone Drug: Placebos Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dexamethasone
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
IV dexamethasone at the dose of 0,2mg/kg = 0,2mL/kg of a solution of 1mg/mL max 8mg
Other Name: IV dexamethasone

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




Primary Outcome Measures :
  1. Morphinic consumption in the post operative 24H [ Time Frame: within 24 hours after dexamethasone or saline serum administration ]
    total morphinic consumption in morphine equivalent in mg


Secondary Outcome Measures :
  1. Delay between the realisation of the lower limb blockade ans the first - consumption of morphinic [ Time Frame: within 24 hours after dexamethasone or saline serum administration ]
    delay in minutes between the realization of the lower limb blockade and the first consumption of morphinic

  2. Duration the the motor blockade [ Time Frame: within 24 hours after dexamethasone or saline serum administration ]
    motor blockade evaluated with the bromide score over 6 points, duration to recover a score of 6/6 (no more blockade) in minutes

  3. Prevalence of post opérative nausea/vomiting [ Time Frame: within 24 hours after dexamethasone or saline serum administration ]
    evaluated with no nausea/vomiting, nausea OR vomiting, nausea AND vomiting



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618173


Contacts
Layout table for location contacts
Contact: Nicolas VAUTRIN 0676430560 nicolas_vautrin@hotmail.fr

Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Layout table for investigator information
Principal Investigator: Claude Meistelman University Professor in CHRU Nancy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03618173    
Other Study ID Numbers: 2018-000314-38
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
dexamethasone
analgesia
lower limb blockade
children
pediatric
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action