Respiratory Distress Syndrome Clinical Trial
Official title:
Premedication for Non-Emergency Endotracheal Intubation In the NICU
Those infants who received the muscle relaxation in combination with the vagolytic (reduce vagus nerve impulses) and pain medication will have reduced time to successful intubation (placement of tube into the lungs), a decrease in the number of attempts, and better intubation conditions reported by the practitioner. The objectives of the study include: 1.) Does the medication protocol outlined in this study provide optimal intubation conditions? (i.e.good jaw relaxation, open and immobile vocal cords and suppression of gag reflex) 2.) Does the addition of a muscle relaxant prior to intubation contribute to less attempts and achieving successful intubation as opposed to neonates who do not receive the muscle relaxant.
The investigators project will study two different strategies of pre-medication in an attempt
to eliminate the pain and discomfort associated with the elective intubation procedure. The
study will be blinded and patients will be randomized in two different arms according to
gestational age and identified by study number for pre-medication protocols. Demographic as
well as study information prior, during and post intubation attempt will be recorded and
closely monitored. Each patient will be monitored for study purposes for at least 24 hours
after intubation attempt to record any potential side effects of the medication. The
investigators plan to have a data safety monitoring board established composed of three
pediatric doctors / specialists not associated with this study.
The response of paralysis, onset and duration will be assessed clinically. Onset of muscle
relaxation will be described as the absence of spontaneous movements and flaccidity, measured
in seconds from the end of the medication administration. Duration of paralysis will be
determined by the difference in time from the onset of paralysis to the return of spontaneous
movements and pre-intubation tone
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