title: Application of Lidocaine Spray for Tracheal Intubation in Neonates - A Clinical Trial Study.
abstract: BACKGROUND
  Tracheal intubation is extremely distressing, painful, and may influence heart rate and blood pressure. Sedatives, analgesics, and muscle relaxants are not commonly used for intubation in neonates.
  
  
  OBJECTIVE
  This study aimed to evaluate the effects of lidocaine spray as a non-intravenous drug before neonatal intubation on blood pressure, heart rate, oxygen saturation and time of intubation.
  
  
  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 infant's care. The allocation concealment was kept in an opaque sealed envelope, and the investigators, the patient 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 participants were 60 neonates with indication of tracheal intubation with gestational age > 30 weeks. Patients in the treatment group received lidocaine 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, oxygen saturation, intubation time and lidocaine side effects were measured before and after intubation.
  
  
  RESULTS
  Totally 60 newborns including 31 boys and 29 girls were entered into the study (drug group n = 30; placebo group n = 30). Boy/girl ratio in treatment and placebo groups were 1.3 and 0.88, respectively. Mean age ± SD of participants 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 lidocaine 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 oxygen 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 oxygen 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 lidocaine 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.
authors.affiliation: Department of Pediatrics,Pediatric research center, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, IR Iran.
authors.forename: Mirhadi
authors.initials: M
authors.lastname: Mussavi
authors.affiliation: Department of Epidemiology, Faculty of Medicine, Ilam University of Medical Sciences, Ilam, IR Iran ; Research Centre for Psychosocial Injuries, Ilam University of Medical Sciences, Ilam, IR Iran.
authors.forename: Khairollah
authors.initials: K
authors.lastname: Asadollahi
authors.affiliation: Department of Gastroenterology, Ilam University of Medical Sciences, Ilam, IR Iran.
authors.forename: Ghobad
authors.initials: G
authors.lastname: Abangah
authors.affiliation: Department of Pediatrics,Pediatric research center, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, IR Iran.
authors.forename: Sirus
authors.initials: S
authors.lastname: Saradar
authors.affiliation: Department of Pharmacology, Iran University of Medical Sciences, Tehran, IR Iran.
authors.forename: Naser
authors.initials: N
authors.lastname: Abbasi
authors.affiliation: Department of Anaesthesiology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, IR Iran.
authors.forename: Fereidon
authors.initials: F
authors.lastname: Zanjani
authors.affiliation: Department of Emergency Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, IR Iran.
authors.forename: Mahsa
authors.initials: M
authors.lastname: Aminizade
keywords: Intratracheal Intubation; Lidocaine Spray; Neonate