Comparison of the effects of intranasal midazolam versus different doses of intranasal ketamine on reducing preoperative pediatric anxiety: a prospective randomized clinical trial.
OBJECTIVE
To compare the effects of intranasal midazolam versus different doses of intranasal ketamine on reducing preoperative pediatric anxiety.


METHODS
The participants of this double-blinded clinical trial study consisted of 120 children aged between 2 and 8 years. They were chosen for elective surgery and randomly assigned to four equal groups. For reducing preoperative anxiety, in the first group midazolam 0.2 mg/kg, in the second group (K1) ketamine 0.5 mg/kg, in the third group (K2) ketamine 3 mg/kg, and in the fourth group normal saline 1 drop/5 kg were administered intranasally. After 15 min, severity of anxiety was assessed with the modified Yale preoperative anxiety score (m-Yale PAS), and level of sedation was evaluated by the Ramsay Sedation Scale before intravenous catheterization. All data were transferred to SPSS-10 software and analyzed statistically with ANOVA, Kruskal-Wallis, and Mann-Whitney tests. A p value < 0.05 was considered meaningful.


RESULTS
The mean of m-Yale PAS in midazolam group was significantly lower than the other three groups (p < 0.05). Regarding this score, there was no significant statistical difference between K2 and normal saline groups (p = 0.944), but the differences between K1 and K2 (p = 0.034) and also between K1 and normal saline (p = 0.049) groups were significant statistically. The Ramsay Sedation Scale in the midazolam group was significantly higher than the other three groups (p < 0.05). By this scale, there was no significant statistical difference between (K2) and normal saline groups (p = 0.940). The differences between (K1) and normal saline (p = 0.045) and also between (K1) and (K2) groups (p = 0.009) were significant statistically.


CONCLUSIONS
Intranasal midazolam was more effective than low- or high-dose intranasal ketamine in reducing preoperative pediatric anxiety. The lower dose of ketamine reduced preoperative anxiety more than a higher dose of ketamine, which may be clinically insignificant.
Department of Anesthesiology, Qazvin University of Medical Sciences, Qazvin, Iran.
S A
SA
Hosseini Jahromi
S M
SM
Hosseini Valami
Nematollah
N
Adeli
Zohreh
Z
Yazdi
D000281:Administration, Intranasal; D000758:Anesthesia; D001007:Anxiety / Q000517:prevention & control* / Q000523:psychology; D001794:Blood Pressure / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D016292:Procedural Sedation; D004311:Double-Blind Method; D017558:Elective Surgical Procedures; D018691:Excitatory Amino Acid Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000627:therapeutic use*; D007649:Ketamine / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008874:Midazolam / Q000008:administration & dosage / Q000627:therapeutic use*; D011300:Preoperative Care / Q000379:methods*; D011446:Prospective Studies; D011594:Psychometrics
D018691:Excitatory Amino Acid Antagonists; D006993:Hypnotics and Sedatives; D007649:Ketamine; D008874:Midazolam