Table 12.28 Cannabinoids for the Acute Management of ABI
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Author Year Country Research Design PEDro Sample Size |
Methods |
Outcomes |
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(2006) Netherlands RCT PEDro=10 N=861 |
Population: TBI; Time Post Injury≤6 hr; GCS Range≤5. Dexanabinol (n=428): Median Age=32 yr; Gender: Male=344, Female=84. Placebo (n=418): Median Age=33 yr; Gender: Male=345, Female=73. Intervention: Patients were randomized to receive either a single intravenous injection of 150mg dexanabinol dissolved in cremophor-ethanol solution or placebo for 15 min. Monitoring occurred for the first 72 hr. Outcomes were assessed 3 mo and 6mo post treatment. Outcome Measures: Glasgow Outcome Scale Extended (GOSE), Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Mortality, Neurological Deterioration. | 1. GOSE scores at 6 mo did not differ between groups (p=0.78). 2. Unfavourable outcome was found in 50% of the treatment group and 51% of controls (OR=1.07). 3. There were no differences in mortality or neurological deterioration between groups. 4. There were no differences in post-treatment ICP or CPP between groups. |
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(2002) Israel RCT PEDro=7 N=67 |
Population: TBI; Dexanabinol (n=30): Mean Age=29 yr; Gender: Male=25, Female=5; Mean Time Post Injury=5 hr; Mean GCS=6.3. Placebo (n=37): Mean Age=31 yr; Gender: Male=32, Female=5; Mean Time Post Injury=4.9 hr; Mean GCS=6.2. Intervention: Patients were randomized to receive either intravenous injection of 50 mg dexanabinol in cremophor-ethanol solution or placebo for 15 min. Monitoring occurred for 10 days. Outcomes were assessed at 10 days 1 mo, 3 mo, and 6 mo post treatment.Outcome Measures: Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Glasgow Outcome Scale (GOS), Disability Rating Scale (DRS), Adverse Events (AEs), Mortality. | 1. Mean percentage of time that ICP>25 mmHg was significantly lower in the treatment group compared to controls on day 2 and 3 (p<0.02 and p<0.005, respectively). 2. Mean percentage time that CPP<50 mmHg was significantly lower in the treatment group compared to controls on days 2 and 3 (p<0.05). 3. On the GOS, a significantly higher proportion of the treatment group had favourable outcomes compared to controls at 1 mo (20% versus 2.7%, p=0.04), with a trend remaining at 3mo (p=0.1). 4. On the DRS, a higher proportion of the treatment group achieved no disability compared to controls. 5. No significant differences were found in AEs or mortality between groups. |
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Dual Cannabinoid Agonist |
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(2012) Germany RCT PEDro=8 N=97 |
Population: TBI; High Dose (HD, n=31): Mean Age=35.6 yr; Gender: Male=21, Female=10. Low Dose (LD, n=33): Mean Age=36.4 yr; Gender: Male=24, Female=9. Placebo (n=33): Mean Age=38.5 yr; Gender: Male=27, Female=6. Intervention: Patients were randomized to receive either placebo, high dose (1000 ug), or low dose (500 ug) of a dual cannabinoid agonist. Outcomes were assessed at 7 days, 14 days, 1 mo, 3 mo, and 6 mo after drug administration. Outcome Measures: Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Survival. | 1. ICP>20 mmHg duration was shorter in the HD and LD groups compared to the placebo group, but this difference was not significant (p>0.05). 2. CPP<60 mmHg duration was significantly lower in the HD group compared to the placebo group (p<0.05). 3. CPP at 7 days was significantly higher in the HD group (p=0.0471) compared to the placebo group, but not in the LD group (p=0.0765) compared to the placebo group. 4. Survival at 1 mo was significantly higher in the HD (p=0.043) and LD (p=0.011) groups compared to the placebo group, but this was not seen at 3mo and 6mo. |