Arya V, Ramji S
Neonatal Division, Department of Pediatrics, Maulana Azad Medical College, New Delhi 110 002, India.
Indian Pediatr. 2001 Sep;38(9):967-72.
To determine efficacy of midazolam as a sedative in mechanically ventilated newborns.
Double blind randomized placebo controlled trial.
Neonatal Unit of Tertiary Hospital.
Sedation over 48 h of observation.
Neonates with birth weight less than 2000 g who were mechanically ventilated within 7 days of life were randomly assigned to midazolam and placebo group. Midazolam and placebo were administered as bolus (0.2 mg/kg) followed by continuous infusion (0.06 mg/kg/h). Both groups received morphine infusion (10 microg/kg/h). Sedation score was noted at 6 hourly intervals for 48 hours. Hemodynamic variables, ventilatory variables, complications and side effects of treatments were also recorded.
Thirty-three neonates were enrolled (17 in midazolam, 16 in placebo group). The groups were comparable for birth weights and gestation. The midazolam group had significantly better sedation from 18-24 hours after enrollment compared to placebo group. At 48 h there were no significant differences in proportion of infants with adequate sedation between midazolam and placebo group. The two groups were comparable with respect to heart rate, perfusion, ventilatory indices and blood gas parameters. None of the infants were noted to have hypotension on loading with midazolam or placebo. Seizures were noted in 2 neonates in placebo group 24 hours after enrollment (insignificant statistically).
Sedation provided by continuous infusion of midazolam and morphine appears to be comparable to morphine alone in newborn babies on mechanical ventilation, with no significant adverse effects. The course of mechanical ventilation is not influenced by use of midazolam.
确定咪达唑仑作为机械通气新生儿镇静剂的疗效。
双盲随机安慰剂对照试验。
三级医院新生儿病房。
48小时观察期内的镇静情况。
出生体重小于2000g且在出生7天内接受机械通气的新生儿被随机分为咪达唑仑组和安慰剂组。咪达唑仑和安慰剂均先静脉推注（0.2mg/kg），然后持续输注（0.06mg/kg/h）。两组均接受吗啡输注（10μg/kg/h）。在48小时内每隔6小时记录一次镇静评分。还记录血流动力学变量、通气变量、治疗并发症及副作用。
共纳入33例新生儿（咪达唑仑组17例，安慰剂组16例）。两组在出生体重和孕周方面具有可比性。与安慰剂组相比，咪达唑仑组在入组后18 - 24小时镇静效果明显更好。48小时时，咪达唑仑组和安慰剂组镇静充分的婴儿比例无显著差异。两组在心率、灌注、通气指标和血气参数方面具有可比性。在给予咪达唑仑或安慰剂负荷剂量时，未观察到婴儿出现低血压。安慰剂组有2例新生儿在入组24小时后出现惊厥（统计学上无显著意义）。
持续输注咪达唑仑和吗啡的镇静效果在机械通气新生儿中似乎与单独使用吗啡相当，且无明显不良反应。咪达唑仑的使用不影响机械通气疗程。
