Application of XXXX Spray for Tracheal Intubation in Neonates - A Clinical Trial Study.

@entity1 @entity26 @entity3303 @entity158
BACKGROUND: Tracheal intubation is extremely distressing, @entity158 , and may influence heart rate and blood pressure. Sedatives, analgesics, and muscle relaxants are not commonly used for intubation in neonates. OBJECTIVES: This study aimed to evaluate the effects of @entity3303 spray as a non-intravenous drug before neonatal intubation on blood pressure, heart rate, @entity26 saturation and time of intubation. @entity1 AND METHODS: In a randomized, controlled study each neonate was randomly assigned to one of the two study groups by staffs who were not involved in the @entity1 's care. The allocation concealment was kept in an opaque sealed envelope, and the investigators, the @entity1 care team, and the assessors were blinded to the treatment allocation. The selected setting was NICU unit of a teaching hospital in Ilam city, Iran and @entity1 were 60 neonates with indication of tracheal intubation with gestational age > 30 weeks. @entity1 in the treatment group received @entity3303 spray and the placebo group received spray of normal saline prior to intubation. Main outcome measurements were the mean rates of blood pressure, heart rate, @entity26 saturation, intubation time and @entity3303 side effects were measured before and after intubation. RESULTS: Totally 60 newborns including 31 @entity1 and 29 @entity1 were entered into the study (drug group n = 30; placebo group n = 30). @entity1 / @entity1 ratio in treatment and placebo groups were 1.3 and 0.88, respectively. Mean age    SD of @entity1 was 34.1    24.8 hours (treatment: 35.3    25.7; placebo: 32.9    24.3; P < 0.0001). Mean weight    SD of neonates was 2012.5    969 g. Application of @entity3303 spray caused a significant reduction of mean intubation time among treatment group compared with placebo group (treatment: 15.03    2.2 seconds; placebo: 18.3    2.3 seconds; P < 0.0001). Mean blood pressure, heart rate and @entity26 saturation rate, among neonates in treatment group was reduced after intubation compared with their relevant figures before intubation; however, their differences were not statistically significant except for mean @entity26 saturation rate that was reduced significantly in placebo group. No side effects were observed during study. CONCLUSIONS: Though the current study revealed some promising results in the application of @entity3303 spray during neonatal intubation without any considerable side effects; however, the current investigation could only be considered as a pilot study for further attempts in different locations with higher sample sizes and in different situations.
