NCT01517828|UnknownPhase 3DMC
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
62
1 country
3
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Anesthesia is rarely used to intubate newborns in delivery room because of the very difficulty of accessing veins. The investigators hypothesized that intranasal administration of sedative would be an effective alternative. -Midazolam and Ketamine are two drugs used during neonates' intubation. They are also used intranasally in the absence of venous access-In a pilot study the investigators have demonstrated that sedation with Midazolam was effective in 67% of the patients. Efficiency was defined by a specific pain score: FANS \< 4 (Faceless Acute Neonatal Pain Scale) and by an impedancemetric Pain monitor \< 0.2 spike/s. The investigators hypothesized that intranasal ketamine would increase procedure effectiveness from 67 to 90%.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 12, 2011
Actual (reported)January 2012
Date type not reportedThis date has not been verified as actual or estimated.
January 25, 2012
Actual (reported)May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Newborns sedation quality
The sedation quality of 2 newborns groups will be compared during the 10 minutes of intubation directly in delivery room and after on the film Pain evaluation done by a Specific clinical Score : the Faceless Acute Neonatal pain Scale (FANS) noted by two independent professional persons. And for Montpellier center, evaluation of pain by cutaneous conductance
during the 10 minutes of intubation
intubation quality
during the 10 minutes of intubation
hemodynamic and respiratory tolerance
during 24 hours after intubation
neurological outcome at 2 years within the 2 groups
2 years after the treatment
Phial of Ketamine (50mg/5ml) will be used and the dose administered will be 2 mg/kg.
Phials of midazolam (5mg/5ml)will be used and the dose administered will be 0.2 ml/kg.
Kétamine (50mg/5ml, Panpharma): for a posology of 2 mg/kg: dose of 0.2 ml/kg Intranasal administration with a 1 ml syringe. Kétamine is a derivated of phencyclidine with a sedative, anesthesic, analgesic and amnesiant activity. Ketamine keeps also a protective reflex of upper respiratory tracts. One injection will be done and if after 7 minutes, newborn is not correctly sedated another dose of same product will be done.
Midazolam (phyal of 5mg/5ml, Mylan S.A.S.) for a posology of 0.2 mg/kg: dose of 0.2 ml/kg Instillation in intranasal with a syringe of 1 ml. Midazolam is an imidazobenzodiazépine, witj a sedative and hypnotic activity,anxiolytic, anti convulsive and muscle relaxant proprieties. One injection will be done and if after 7 minutes, newborn is not correctly sedated another dose of same product will be done.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Administration procedure
Sedation by ketamine
The registry describes an administration procedure or treatment schedule. Actual exposure and doses are not established by this entry.
View registry recordAdministration procedure
Sedation with Midazolam
The registry describes an administration procedure or treatment schedule. Actual exposure and doses are not established by this entry.
View registry recordCentre Hospitalier Universitaire
Montpellier, 34000, France
Centre Hospitalier Universitaire
Nîmes, 30000, France
Centre Hospitalier Général
Perpignan, 66000, France
Milesi C, Baleine J, Mura T, Benito-Castro F, Ferragu F, Thiriez G, Thevenot P, Combes C, Carbajal R, Cambonie G. Nasal midazolam vs ketamine for neonatal intubation in the delivery room: a randomised trial. Arch Dis Child Fetal Neonatal Ed. 2018 May;103(3):F221-F226. doi: 10.1136/archdischild-2017-312808. Epub 2017 Aug 17.
Christophe CM MILESI, MD
University Hospital, Montpellier
62 participants (actual enrollment reported by the registry).
First Submitted
December 12, 2011
First Posted
January 25, 2012
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 3, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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