PURPOSE: We compare the efficacy and safety profile of oral midazolam and continuous flow50% nitrous oxide (N(2)O) for alleviating anxiety and pain during voiding cystourethrography (VCU) in children. MATERIALS AND METHODS: This prospective, randomized clinical trial study was conducted in the radiology unit of a tertiary care center. Children older than 3 years scheduled forVCU were given either 0.5 mg/kg midazolam orally or continuous flow 50% N(2)O. Main outcomes were degree of anxiety and pain as assessed by the attending nurse and radiologist performing the test using a behavioral anxiety score, a distress score and an overall satisfaction score, side effects and recovery profile. RESULTS: The study included 47 children (89% girls) with a mean age of 6 years (range 3 to 15). There were 24 subjects in the midazolam group and 23 in the N(2)O group. Midazolam and N(2)O provided adequate anxiety and pain relief to perform the examination, yet children given N(2)O required less restraining and experienced a significantly shorter recovery time (29 +/- 10 vs 63 +/- 25 minutes, p <0.001). CONCLUSIONS:Continuous flow 50% nitrous oxide and oral midazolam are comparably safe and effective in reducing anxiety and distress during VCU in children older than 3 years. However, N(2)O provides a more rapid onset of sedating effect and has a shorter recovery time.
RCT Entities:
PURPOSE: We compare the efficacy and safety profile of oral midazolam and continuous flow 50% nitrous oxide (N(2)O) for alleviating anxiety and pain during voiding cystourethrography (VCU) in children. MATERIALS AND METHODS: This prospective, randomized clinical trial study was conducted in the radiology unit of a tertiary care center. Children older than 3 years scheduled for VCU were given either 0.5 mg/kg midazolam orally or continuous flow 50% N(2)O. Main outcomes were degree of anxiety and pain as assessed by the attending nurse and radiologist performing the test using a behavioral anxiety score, a distress score and an overall satisfaction score, side effects and recovery profile. RESULTS: The study included 47 children (89% girls) with a mean age of 6 years (range 3 to 15). There were 24 subjects in the midazolam group and 23 in the N(2)O group. Midazolam and N(2)O provided adequate anxiety and pain relief to perform the examination, yet children given N(2)O required less restraining and experienced a significantly shorter recovery time (29 +/- 10 vs 63 +/- 25 minutes, p <0.001). CONCLUSIONS: Continuous flow 50% nitrous oxide and oral midazolam are comparably safe and effective in reducing anxiety and distress during VCU in children older than 3 years. However, N(2)O provides a more rapid onset of sedating effect and has a shorter recovery time.
Authors: Nader Shaikh; Alejandro Hoberman; Ron Keren; Anastasia Ivanova; Harvey A Ziessman; Gang Cui; Tej K Mattoo; Sonika Bhatnagar; Milan D Nadkarni; Marva Moxey-Mims; William A Primack Journal: Pediatr Radiol Date: 2016-06-10