This study was performed to evaluate the effect of oral midazolam on pre-procedural, procedural and post-procedural conscious sedation in children undergoing upper 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 premeditation prior to IV insertion 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 parental separation; 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: patient's anxiety and level of sedation for IV placement (p=0.00006); level of pre-procedural sedation (p=0.00113) and post-procedural sedation (p=0.025); ease of parental separation (p=0.022); ease of the nursing personnel's ability to monitor the patient during the procedure (p=0 0012); and the patient's amnesia to an object shown immediately before beginning the endoscopy (p=0.00112). No significant difference was noted between the placebo group and the oral midazolam group with regard to the length or performance of the procedure; recovery time; or in the dose of IV medication required for successful completion of the endoscopy [IV midazolam 0 113 mg/kg (placebo) vs 0.104 mg/kg (study); IV meperidine 1.82 mg/kg (placebo) vs 1.96 mg/kg (study); IV fentanyl 3.01 meg/kg (placebo) vs 2.75 meg/kg (study)]. CONCLUSION: Oral midazolam is an effective pa-medication for children undergoing upper endoscopy. It provides an increased level of sedation and amnesia when compared to placebo. However, it does not appear to shorten procedure time or decrease the amount of IV medication needed to perform the endoscopy Oral midazolam is effective and safe and can be used in anxious children and in patients previously judged to be difficult to sedate.
All Science Journal Classification (ASJC) codes
- Radiology Nuclear Medicine and imaging