Intranasal Midazolam Versus Intranasal Ketamine to Sedate Newborns for Intubation in Delivery Room
Status:
Unknown status
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
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%.
- Main objective: To compare newborns sedation quality as they are sedated either by
intranasal Midazolam or by intranasal Ketamine during intubation in delivery room.
- Secondary Objectives: To compare intubation quality, hemodynamic and respiratory
tolerance, and neurological outcomeat 2 years within the two groups.