PLACEBO-CONTROLLED TRIAL ASSESSING THE USE OF ORAL MIDAZOLAM AS A PREMEDICATION TO CONSCIOUS SEDATION FOR PEDIATRIC ENDOSCOPY

Background: This study was performed to evaluate the effect of midazol am, as premedication before intravenous conscious sedation, on preproc edural, procedural, and post-procedural patient comfort and anxiety in children undergoing endoscopy. Methods: A placebo-controlled, double- blind, randomized study was conducted in 123 children (age 7.75 +/- 4. 46 years, 56% male) using oral midazolam (0.5 mg/kg, maximum 20 mg) as a premedication before insertion of an intravenous access device (IV) and upper endoscopy. Patients were evaluated with regard to changes i n vital signs, level of sedation during IV placement, level of pre-and post-procedure conscious sedation, ease of separation from parents, e ase and duration of procedure, recovery time, and amnesia to objects s hown before IV placement and immediately before the start of the proce dure. Results: A significant difference was noted in the study group f or the following parameters: level of sedation for IV placement (p < 0 .0001), pre-procedural sedation (p < 0.001), ease of IV insertion (p < 0.003), ease of separation from parents (p = 0.022), and ease of the nursing personnel's ability to monitor the patient during the procedur e (p = 0.0012). The patient's amnesia to an object shown immediately b efore beginning the endoscopy was increased (p < 0.001). Patients and parents were also more satisfied with the procedure process (p < 0.05) . No significant difference was noted with regard to the length or per formance of the procedure or recovery time or in the dose of IV medica tion required for successful completion of the endoscopy. Conclusion: Oval midazolam is an effective and safe premedication for children und ergoing upper endoscopy and should be used in all anxious children and in patients previously judged to be difficult to sedate.