Placebo-controlled trial assessing the use of oral midazolam as a premedication to conscious sedation for pediatric endoscopy

Abstract

Background: This study was performed to evaluate the effect of midazolam, as premedication before intravenous conscious sedation, on pre-procedural, 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 in vital signs, level of sedation during IV placement, level of pre- and post-procedure conscious sedation, ease of separation from parents, ease and duration of procedure, recovery time, and amnesia to objects shown before IV placement and immediately before the start of the procedure. Results: A significant difference was noted in the study group for 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 procedure ( p = 0.0012). The patient's amnesia to an object shown immediately before 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 performance of the procedure or recovery time or in the dose of IV medication required for successful completion of the endoscopy. Conclusion: Oral midazolam is an effective and safe premedication for children undergoing upper endoscopy and should be used in all anxious children and in patients previously judged to be difficult to sedate. (Gastrointest Endosc 1998;47:455-60.)