BACKGROUND: This study was designed to evaluate the efficacy and safety of oral midazolam, tramadol drops, and intranasal sufentanil for premedication of pediatric patients. METHODS:Sixty children, three to 10 years of age, who were designated as American Society of Anesthesiologists physical status 1 and who were undergoing adenotonsillectomy as inpatients were randomized to receive a dosage of 0.5 mg/kg (total of 4 ml) midazolam in cherry juice (n=20, Group M), 3 mg/kg tramadol drops (n=20, Group T), or 2 microg/kg intranasal sufentanil (n=20, Group S). Clinical responses (sedation, anxiolysis, cooperation) and adverse effects (respiratory, hemodynamic, etc.) were recorded. Safety was assessed by continuous oxygen saturation monitoring and observation. Vital signs (blood pressure, pulse, oxygen saturation, respiratory rate) were recorded before drug administration (baseline) and then every 10 minutes until the induction of anesthesia. RESULTS:Mean blood pressure decreased significantly after five minutes of intranasal sufentanil administration relative to Groups M (p < 0.01) and T (p < 0.05), whereas heart rate remained unchanged. Oxygen saturation and respiratory rate decreased significantly after 20 and 30 minutes of intranasal sufentanil administration relative to Groups M and T (p < 0.05). Anxiety scores showed rates of 45 percent in Group M, 5 percent in Group T, and 40 percent in Group S. Anxiety scores in Groups M and S were better than those of Group T (p < 0.01). Cooperation scores for face-mask acceptance showed rates of 85 percent in Group M, 45 percent in Group T, and 85 percent in Group S (p < 0.01). CONCLUSION:Intranasal sufentanil and oral midazolam are more appropriate premedication options than tramadol drops in children.
RCT Entities:
BACKGROUND: This study was designed to evaluate the efficacy and safety of oral midazolam, tramadol drops, and intranasal sufentanil for premedication of pediatric patients. METHODS: Sixty children, three to 10 years of age, who were designated as American Society of Anesthesiologists physical status 1 and who were undergoing adenotonsillectomy as inpatients were randomized to receive a dosage of 0.5 mg/kg (total of 4 ml) midazolam in cherry juice (n=20, Group M), 3 mg/kg tramadol drops (n=20, Group T), or 2 microg/kg intranasal sufentanil (n=20, Group S). Clinical responses (sedation, anxiolysis, cooperation) and adverse effects (respiratory, hemodynamic, etc.) were recorded. Safety was assessed by continuous oxygen saturation monitoring and observation. Vital signs (blood pressure, pulse, oxygen saturation, respiratory rate) were recorded before drug administration (baseline) and then every 10 minutes until the induction of anesthesia. RESULTS: Mean blood pressure decreased significantly after five minutes of intranasal sufentanil administration relative to Groups M (p < 0.01) and T (p < 0.05), whereas heart rate remained unchanged. Oxygen saturation and respiratory rate decreased significantly after 20 and 30 minutes of intranasal sufentanil administration relative to Groups M and T (p < 0.05). Anxiety scores showed rates of 45 percent in Group M, 5 percent in Group T, and 40 percent in Group S. Anxiety scores in Groups M and S were better than those of Group T (p < 0.01). Cooperation scores for face-mask acceptance showed rates of 85 percent in Group M, 45 percent in Group T, and 85 percent in Group S (p < 0.01). CONCLUSION: Intranasal sufentanil and oral midazolam are more appropriate premedication options than tramadol drops in children.