Efficiency of IV Dexamethasone, Administered After a Lower Limb Blockade, on the Post Operative Pain in Children (DEXPED)
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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).
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.
IV saline serum at the dose of 0,2mL/kg maximum 8mL
Other Name: IV saline serum
- 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
- 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
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618173
|Contact: Nicolas VAUTRINemail@example.com|
|Principal Investigator:||Claude Meistelman||University Professor in CHRU Nancy|