Protective effect of Fentanyl on oropharyngeal trauma in neonatal intubation

2015-12-01

2016-05-01

The aim of this study was to evaluate the efficacy and safety of Fentanyl as a premedication and its impact in accelerating the endotracheal intubation in neonates at the neonatal intensive care unit.

In this prospective double-blind randomized controlled trial, newborns of gestational age ≥28 weeks postnatal ages less than 3 days admitted to the neonatal intensive care unit of Alzahra Hospital Izadi Hospital and Hazrat Masumeh Hospital (in Qom city),, Iran with length of stay at least 72 h requiring an elective endotracheal intubation or tube exchange were randomly assigned in two groups. Neonates with upper airway anomalies which made intubation difficult and cyanotic and congenital heart disease, neuromuscular diseases, and clinical syndromes were excluded from the study. Infants with 3 or more times of unsuccessful attempts of endotracheal intubation were also excluded. For the case group (n= 44), Fentanyl (made by Caspian Company, Iran country) was administered 3 mcg/kg slow IV push in 1 mL normal saline in five minutes before intubation, and the control group (n= 51) received 1 mL normal saline five minutes before intubation. From 5 minutes before the procedure until 5 minutes after that, heart rate, blood pressure and arterial blood oxygen saturation were recorded by Hewellett Packard monitor.
Prior to intubation, all neonates were ventilated with 100% oxygen for one minute to increase the SpO2 over 94%. Laryngoscopy was performed using the Riester laryngoscope by an expert nurse in NICU who was unaware about the type of the medication used.
The primary outcome was time to successful intubation which was from the time of laryngoscope insertion into the mouth until its removal after successful intubation and was recorded with chronometer by another nurse who was unaware of the type of the drug administered. Adverse events including difficulty in intubation due to the laryngospasm or the blood found due to the damage to the mucosa of the mouth and tracheal rupture were reported and compared in both groups.
Heart rate and arterial blood oxygen saturation changes before, during, and after the procedure were calculated. Blood pressure was not accessible during intubation due to the movement of neonates and it was only recorded before and after the procedure.

The participants were randomly assigned, following simple randomization procedures (1 : 1),

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