A Placebo-Controlled Randomized Trial Comparing Oral Midazolam, Dexmedetomidine, and Gabapentin on Prophylaxis of Emergence Agitation After Sevoflurane Anesthesia in Adenotonsillectomy.

Abstract

Background: Sevoflurane causes emergence agitation (EA) in up to 80% of pediatric patients.

Objectives: Using midazolam, dexmedetomidine (DEX), and gabapentin, this work aimed to assess the prophylactic effect of oral premedication on EA incidence experienced by pediatric patients during recovery from sevoflurane anesthesia.

Study design: Randomized controlled trial.

Setting: Kafrelsheikh University, Kafrelsheikh, Egypt.

Methods: This study was performed on 240 men and women aged 3 to 10 years who were scheduled for adenotonsillectomy. Patients were randomized into 4 equal-sized groups. Thirty minutes before general anesthesia, oral premedication was applied in the form an apple-flavored sugary fluid plus 0.5 mg/kg of midazolam in Group M, 4 µg/kg of DEX in Group D, 10 mg/kg of gabapentin in Group G, or no drugs whatsoever in Group P (placebo).

Results: The incidence of EA was reduced more greatly in the M, D, and G groups than in the P group, and the D group's incidence of EA was lower than that of the M or G groups. The severity of EA exhibited a more significant reduction in the M, D, and G groups than in Group P. Similarly, the time until extubation was more prolonged in the M, D, and G groups than it was in the P group. Hemodynamics measurements were significantly lower in Groups M, D, and G than in Group P, and the D group had a lower hemodynamics measurement than did the M or G groups. Sedation scores were greater in the D and G groups than in the P group, and the D group had a higher sedation score than did Group M.

Limitations: This study used a small sample, took place at a single center, and had a short follow-up period.

Conclusion: Premedication using oral midazolam, DEX, or gabapentin reduced the incidence of EA, and DEX provided the best sedation and hemodynamics of all.