Objectives: This study was performed to compare the effects of oral midazolam and oral diazepam, administered with intravenous (IV) meperidine, on pre-procedural, procedural, and post-procedural sedation and recovery in children undergoing diagnostic upper endoscopy. The costs of pre-procedure sedation were compared for the two benzodiazepines.
Methods: A randomized, double-blind study was conducted in 154 children (mean age 96.73 +/- 59.34 months, 53% male) undergoing endoscopy. Oral midazolam (0.5 mg/kg, maximum dose of 20 mg) or oral diazepam (0.3 mg/kg, maximum dose of 10 mg) was given before IV insertion, and with IV meperidine (2 mg/kg, maximum dose of 100 mg) given to all patients just before upper endoscopy. Further "rescue" midazolam doses (to a maximum cumulative dose of 5 mg) were given as needed to achieve a pre-procedure sedation score of > or =2. All patients received intravenous propofol for procedural sedation. Patients were evaluated for the efficacy and safety of pre-procedural sedation, sedation during upper endoscopy, and recovery following completion of the procedure.
Results: There were no significant differences between study groups for level of pre-procedural sedation, need for midazolam rescue in endoscopy, effectiveness of procedural sedation, occurrence of adverse events, and recovery parameters.
Conclusions: Oral midazolam and diazepam, in conjunction with IV administration of meperidine, provide comparable, effective, and safe premedication for children undergoing upper endoscopy. The cost of midazolam was substantially higher than diazepam.