IV Drug UsagePhase 3DEXPEDNCT03618173
Efficiency of IV Dexamethasone, Administered After a Lower Limb Blockade, on the Post Operative Pain in Children
A Phase 3 study testing Dexamethasone in people with IV Drug Usage, run by Central Hospital, Nancy, France.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- IV Drug Usage
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Sep 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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 ...).
Read more
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
Read the detailed description
Time 1: Pre-anesthetic consultation
Recruitment is performed during the pre-anesthetic consultation, between D-90 and D-2 of the date of operation. The eligibility criteria will be checked and if the child is eligible to participate in the study, oral and written information about the study is given to the child's parents (or, failing that, to their legal representatives) by the anesthetist doctor. Minors will receive information adapted to their ability to understand. It can not be overridden by the refusal of the child or the revocation of his acceptance. The investigator will give the parents the consent form The parents then have a minimum of 48 hours to decide whether to participate in the study of their child.
In all cases, an anesthesiologist doctor will be reachable (through the secretariat) at any time in case of additional questions during the reflection period.
Time n ° 2: Pre-anesthetic visit
If the parents and the child agree to participate in this study and after a new eligibility check, the consent signed by both parents will be collected the day before the intervention during the pre-anesthetic visit.
The randomization will then be carried out and two groups will be created:
- A first group receiving 0.2 mg / kg of IV dexamethasone at the time of anesthetic induction
- A second group receiving the same volume of placebo (physiological saline)
The anesthetist will send to the pharmacy, on a prescription, the results of the randomization (assignment code) the day before the procedure.
The drugs in the study will be prepared by the pharmacy department of the University Hospital of Nancy at most 21 days in advance of the intervention. Indeed, a syringe for each randomization list (stratification on algebra level) will always be planned in advance and ready to be used for inclusion early in the morning (between 7:30 and 9:30).
The packaging will be identical to guarantee the double blind. The pharmacy will send the drug to the operating room on the morning of the operation via a specific drug transport.
On the morning of the operation, all patients included will receive a premedication with midazolam 0.3mg / kg per os 30 minutes max 10mg before surgery.
The patient is then asleep (general anesthesia) according to the protocols in force (initial induction by inhaled sevoflurane and then peripheral venous route (VVP) and injection of sufentanil 0.1 gamma / kg and propofol 2-3mg / kg or VVP pose then IV anesthesia directly in the larger ones).
Then a block of the lower limb with 0.3mL / kg of ropivacaine at the concentration of 2mg / mL, ultrasound guided with or without neurostimulation is performed.
The patient then receives according to his group:
- either 0.2 mg / kg of IV dexamethasone at the time of anesthetic induction
- or the same volume of placebo (physiological saline) at the time of anesthetic induction.
Maintenance of general anesthesia is done by sevoflurane with sufentanil reinjection at the discretion of the anesthesiologist.
In the intraoperative period, the patient will receive a systematic injection of paracetamol 15mg / kg IVL 30 minutes before the end of the surgical procedure.
Once the operation is complete, the patient is transferred to the post-interventional surveillance room with awakening and evaluation of the pain (by EVA scale) and postoperative nausea (by questioning the child), noting the hours of statement. The existence of a motor block of the operated lower limb is also evaluated and recorded. Thereafter, the patient returns to conventional service with regular evaluation (every 4 hours) of pain and nausea / vomiting (every 4 hours).
The pain intensity will be evaluated by a scale validated from the age of 6: evaluation by analogue verbal scale (EVA) giving a painful intensity over 100: 100/100 being the maximum intensity imaginable, 0/100 the absence of pain.
The occurrence of postoperative nausea and vomiting will be assessed as follows: no nausea / vomiting, nausea without vomiting, nausea and vomiting.
If the EVA is greater than 30 in the 24 hours postoperative: an injection of Nalbuphine 0.2mg / kg IVL or morphine 0.1mg / kg max 3mg every 4 to 6 hours will be performed; in the event of failure (persistence of an EVA> 30 to 30 mins), a new dose of paracetamol 15mg / kg may be administered again 6 hours after the first dose injected intraoperatively.
In the event of nausea and / or postoperative vomiting, ondansetron 0.1mg / kg every 8h will be administered and then in case of failure at 30 minutes, droperidol 10 microgram / kg every 8h.
- Conditions
- IV Drug Usage
- Being tested
- Dexamethasone, Placebos
- Keywords
- dexamethasone, analgesia, lower limb blockade, children, pediatric
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called IV dexamethasone
IV dexamethasone at the dose of 0,2mg/kg = 0,2mL/kg of a solution of 1mg/mL max 8mg
PlacebosDrug
Also called IV saline serum
IV saline serum at the dose of 0,2mL/kg maximum 8mL
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphinic consumption in the post operative 24H
total morphinic consumption in morphine equivalent in mg
Measured: 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
delay in minutes between the realization of the lower limb blockade and the first consumption of morphinic
Measured: within 24 hours after dexamethasone or saline serum administration
Duration the the motor blockade
motor blockade evaluated with the bromide score over 6 points, duration to recover a score of 6/6 (no more blockade) in minutes
Measured: within 24 hours after dexamethasone or saline serum administration
Prevalence of post opérative nausea/vomiting
evaluated with no nausea/vomiting, nausea OR vomiting, nausea AND vomiting
Measured: within 24 hours after dexamethasone or saline serum administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IV Drug UsageStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude Meistelman, Principal investigator, University Professor in CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618173
- Sponsor's protocol ID
- 2018-000314-38
- Other IDs
- 2018
- Acronym
- DEXPED
- Status last verified
- Jul 2018
- First submitted
- 1 Aug 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32998920
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03618173
- Acronym / sponsor ID
- DEXPED / 2018-000314-38
- Conditions
- IV Drug Usage
- Keywords
- dexamethasone, analgesia, lower limb blockade, children, pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Time 1: Pre-anesthetic consultation
Recruitment is performed during the pre-anesthetic consultation, between D-90 and D-2 of the date of operation. The eligibility criteria will be checked and if the child is eligible to participate in the study, oral and written information about the study is given to the child's parents (or, failing that, to their legal representatives) by the anesthetist doctor. Minors will receive information adapted to their ability to understand. It can not be overridden by the refusal of the child or the revocation of his acceptance. The investigator will give the parents the consent form The parents then have a minimum of 48 hours to decide whether to participate in the study of their child.
In all cases, an anesthesiologist doctor will be reachable (through the secretariat) at any time in case of additional questions during the reflection period.
Time n ° 2: Pre-anesthetic visit
If the parents and the child agree to participate in this study and after a new eligibility check, the consent signed by both parents will be collected the day before the intervention during the pre-anesthetic visit.
The randomization will then be carried out and two groups will be created:
- A first group receiving 0.2 mg / kg of IV dexamethasone at the time of anesthetic induction
- A second group receiving the same volume of placebo (physiological saline)
The anesthetist will send to the pharmacy, on a prescription, the results of the randomization (assignment code) the day before the procedure.
The drugs in the study will be prepared by the pharmacy department of the University Hospital of Nancy at most 21 days in advance of the intervention. Indeed, a syringe for each randomization list (stratification on algebra level) will always be planned in advance and ready to be used for inclusion early in the morning (between 7:30 and 9:30).
The packaging will be identical to guarantee the double blind. The pharmacy will send the drug to the operating room on the morning of the operation via a specific drug transport.
On the morning of the operation, all patients included will receive a premedication with midazolam 0.3mg / kg per os 30 minutes max 10mg before surgery.
The patient is then asleep (general anesthesia) according to the protocols in force (initial induction by inhaled sevoflurane and then peripheral venous route (VVP) and injection of sufentanil 0.1 gamma / kg and propofol 2-3mg / kg or VVP pose then IV anesthesia directly in the larger ones).
Then a block of the lower limb with 0.3mL / kg of ropivacaine at the concentration of 2mg / mL, ultrasound guided with or without neurostimulation is performed.
The patient then receives according to his group:
- either 0.2 mg / kg of IV dexamethasone at the time of anesthetic induction
- or the same volume of placebo (physiological saline) at the time of anesthetic induction.
Maintenance of general anesthesia is done by sevoflurane with sufentanil reinjection at the discretion of the anesthesiologist.
In the intraoperative period, the patient will receive a systematic injection of paracetamol 15mg / kg IVL 30 minutes before the end of the surgical procedure.
Once the operation is complete, the patient is transferred to the post-interventional surveillance room with awakening and evaluation of the pain (by EVA scale) and postoperative nausea (by questioning the child), noting the hours of statement. The existence of a motor block of the operated lower limb is also evaluated and recorded. Thereafter, the patient returns to conventional service with regular evaluation (every 4 hours) of pain and nausea / vomiting (every 4 hours).
The pain intensity will be evaluated by a scale validated from the age of 6: evaluation by analogue verbal scale (EVA) giving a painful intensity over 100: 100/100 being the maximum intensity imaginable, 0/100 the absence of pain.
The occurrence of postoperative nausea and vomiting will be assessed as follows: no nausea / vomiting, nausea without vomiting, nausea and vomiting.
If the EVA is greater than 30 in the 24 hours postoperative: an injection of Nalbuphine 0.2mg / kg IVL or morphine 0.1mg / kg max 3mg every 4 to 6 hours will be performed; in the event of failure (persistence of an EVA> 30 to 30 mins), a new dose of paracetamol 15mg / kg may be administered again 6 hours after the first dose injected intraoperatively.
In the event of nausea and / or postoperative vomiting, ondansetron 0.1mg / kg every 8h will be administered and then in case of failure at 30 minutes, droperidol 10 microgram / kg every 8h.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone | Experimental | Drug: DexamethasoneIV 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). |
| Placebos | Placebo comparator | Drug: PlacebosIV placebo group : saline serum is administrated at the induction of general anesthesia, at the dose of 0,2mL/kg, maximum 8mL. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: IV dexamethasoneIV dexamethasone at the dose of 0,2mg/kg = 0,2mL/kg of a solution of 1mg/mL max 8mg | Drug | dexamethasone |
| PlacebosAlso: IV saline serumIV saline serum at the dose of 0,2mL/kg maximum 8mL | Drug | Placebos |
Primary outcome
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
3 secondary outcomes
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
Duration the the motor blockade
Time frame: within 24 hours after dexamethasone or saline serum administration
Prevalence of post opérative nausea/vomiting
Time frame: within 24 hours after dexamethasone or saline serum administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Derived from this study: PubMed 32998920Vautrin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Meistelman principal investigator
University Professor in CHRU Nancy
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with IV Drug Usage, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas VAUTRIN (0676430560, nicolas_vautrin@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphinic consumption in the post operative 24H (time frame: within 24 hours after dexamethasone or saline serum administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03618173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.