PURPOSE: 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. CONCLUSION: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.
RCT Entities:
PURPOSE: 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. CONCLUSION: 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.
Authors: Thomas Cristoforo; Dulce Gonzalez; Mark Bender; Geraldine Uy; Linda Papa; Bertha A Ben Khallouq; Mark Clark; Brandon Carr; Kelly Cramm Journal: J Child Adolesc Trauma Date: 2021-09-13