Table 12.49 Midazolam for the Acute Management of ABI
Author Year Country Research Design PEDro Sample Size |
Methods |
Outcomes |
(2008) Ireland RCT PEDro=8 N=30 |
Population: TBI; Midazolam (MDZ, n=15): Age Range: 18-65 yr; Gender: Male=14, Female=1; Mean Time Since Injury=12.86 hr; Median GCS=4.73. Propofol (PROP, n=13): Age Range: 18-65 yr; Gender: Male=13, Female=0; Mean Time Since Injury=9.07 hr; Median GCS=5.07. Intervention: Patients were randomly allocated to receive MDZ (n=15) or PROP (n=13) sedation. Outcomes were assessed at baseline and 3 mo. Outcome Measures: Glasgow Outcome Score (GOS), Mortality, Disability. | 1. There was no significant difference between MDZ and PROP groups in number of patients with good outcomes (53% versus 54%). 2. Of the patients who had a poor outcome, there was no significant difference in the mortality rate between MDZ and PROP groups (20% versus 38%; p=0.07). 3. Of the patients who had a poor outcome, there was no significant difference in the severe disability rate between MDZ and PROP groups (20% versus 15%; p=0.8). |
Sanchez-Izquierdo-Riera et al. (1998) Spain RCT PEDro=5 N=100 |
Population: TBI; Mean Age=35.4 yr; Gender: Male=75, Female=25. Intervention: Patients were randomized to receive continuous intravenous infusion of midazolam (0.1-0.35 mg/kg/hr,n=34), propofol at 1.5- 6mg/kg/hr (n=33), or propofol at 0.1-0.2 mg/kg/hr (n=33). All patients received morphine. Outcome Measures: Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Triglyceride levels, Wake-up time, Sedation. | 1. No significant differences were found in ICP or CPP among treatment groups. 2. High levels of triglyceride were found in patients receiving propofol (p<0.05). 3. Wake-up time was significantly shorter in patients receiving propofol compared to those receiving midazolam (110 min/190 min versus 660 min, p<0.01). 4. All regimens achieved similar levels of sedation and had similar incidences of adverse effects. |
(2001) USA Case Series N=184 |
Population: TBI; Northern Cohort (n=66): Mean Age=32.9 yr; Gender: Male=53, Female=13. Southern Cohort (n=118): Mean Age=31.2 yr; Gender: Male=89, Female=29. Intervention: Patients received 0.1 mg/kg midazolam without a restricted maximal dose (Group 1) or with a maximal dose of 5 mg (Group 2). Outcome Measures: Systolic Blood Pressure (SBP), Hypotension, Dose. | 1. Patients in the Group 1 received significantly higher doses than those in Group 2 (0.106 mg/kg versus 0.059mg/kg, p<0.0001). 2. A significant relationship was found between dose and hypotension following intubation (p=0.032) as well as decrease in SBP (p=0.022). |
(1993) France Case Series N=12 |
Population: TBI; Mean Age=28.3 yr; Gender: Male=11, Female=1; Mean GCS=5.2. Intervention: Patients received intravenous infusion of 0.15 mg/kg midazolam over a 1min period. Outcome Measures: Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Mean Arterial Pressure (MAP). | 1. Significant reductions in MAP (89 mmHg to 75 mmHg, p<0.0001) and CPP (71 mmHg to 55.8 mmHg, p<0.0001) were observed, but not in ICP. 2. Patients with low initial ICP (<18 mmHg) experienced greater reductions in MAP and greater increases in ICP compared to those with high initial ICP (≥18 mmHg; p<0.0001). |
Multimodal Midazolam Interventions |
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(1994) UK PCT N=15 |
Population: ABI; Propofol (PROP, n=9): Mean Age=30.5 yr; Gender: Male=8, Female=1; Severity of Injury: Moderate=2, Severe=7; Morphine and Midazolam (M+M, n=6): Mean Age=30.5 yr; Gender: Male=6, Female=0; Severity of Injury: Moderate=1, Severe=5. Intervention: Patients received sedation with either PROP (150-400 mg/hr) or morphine (0-4 mg/hr) with midazolam (0-5 mg/hr). Outcome Measures: Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Mean Arterial Pressure (MAP), Global Brain Metabolism (AVDO2), Glasgow Outcome Scale (GOS). | 1. PROP led to a decrease in AVDO2 at 4 hr (6.0±2.6 mL/dL to 3.0±0.6 mL/dL, p<0.02). 2. No difference was reported between groups in ICP, CPP, and MAP. 3. No difference was reported between groups in functional outcomes on GOS at 6mo. |