Anticonvulsant therapy for status epilepticus

Kameshwar Prasad; Khaldoon Al‐Roomi; Pudukode R Krishnan; Reginald Sequeira

doi:10.1002/14651858.CD003723.pub2

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Analysis 1.1

Comparison 1 Lorazepam IV versus diazepam IV, Outcome 1 Non‐cessation of seizures.

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Analysis 1.2

Comparison 1 Lorazepam IV versus diazepam IV, Outcome 2 Requirement for ventilatory support.

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Analysis 1.3

Comparison 1 Lorazepam IV versus diazepam IV, Outcome 3 Adverse effects.

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Analysis 1.4

Comparison 1 Lorazepam IV versus diazepam IV, Outcome 4 Continuation of status requiring a different drug or general anaesthesia.

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Analysis 1.5

Comparison 1 Lorazepam IV versus diazepam IV, Outcome 5 Death.

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Analysis 2.1

Comparison 2 Lorazepam IV versus placebo IV, Outcome 1 Non‐cessation of seizures.

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Analysis 2.2

Comparison 2 Lorazepam IV versus placebo IV, Outcome 2 Requirement for ventilatory support.

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Analysis 2.3

Comparison 2 Lorazepam IV versus placebo IV, Outcome 3 Adverse effects.

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Analysis 2.4

Comparison 2 Lorazepam IV versus placebo IV, Outcome 4 Continuation of status requiring a different drug or general anaesthesia.

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Analysis 2.5

Comparison 2 Lorazepam IV versus placebo IV, Outcome 5 Death.

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Analysis 3.1

Comparison 3 Lorazepam IV versus diazepam plus phenytoin IV, Outcome 1 Non‐cessation of seizures.

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Analysis 3.2

Comparison 3 Lorazepam IV versus diazepam plus phenytoin IV, Outcome 2 Adverse effects.

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Analysis 4.1

Comparison 4 Lorazepam IV versus phenobarbitone IV, Outcome 1 Non‐cessation of seizures.

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Analysis 4.2

Comparison 4 Lorazepam IV versus phenobarbitone IV, Outcome 2 Adverse effects.

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Analysis 5.1

Comparison 5 Lorazepam IV versus phenytoin IV, Outcome 1 Non‐cessation of seizures.

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Analysis 5.2

Comparison 5 Lorazepam IV versus phenytoin IV, Outcome 2 Adverse effects.

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Analysis 6.1

Comparison 6 Midazolam IV versus lorazepam IV, Outcome 1 Non‐cessation of seizures.

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Analysis 6.2

Comparison 6 Midazolam IV versus lorazepam IV, Outcome 2 Requirement for ventilatory support.

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Analysis 6.3

Comparison 6 Midazolam IV versus lorazepam IV, Outcome 3 Adverse effects.

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Analysis 6.4

Comparison 6 Midazolam IV versus lorazepam IV, Outcome 4 Continuation of status requiring a different drug or general anaesthesia.

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Analysis 7.1

Comparison 7 Midazolam IV versus diazepam IV, Outcome 1 Non‐cessation of seizures.

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Analysis 7.2

Comparison 7 Midazolam IV versus diazepam IV, Outcome 2 Requirement for ventilatory support.

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Analysis 7.3

Comparison 7 Midazolam IV versus diazepam IV, Outcome 3 Adverse effects.

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Analysis 7.4

Comparison 7 Midazolam IV versus diazepam IV, Outcome 4 Death.

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Analysis 8.1

Comparison 8 Midazolam IM versus diazepam IV, Outcome 1 Non‐cessation of seizures.

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Analysis 8.2

Comparison 8 Midazolam IM versus diazepam IV, Outcome 2 Requirement for ventilatory support.

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Analysis 8.3

Comparison 8 Midazolam IM versus diazepam IV, Outcome 3 Adverse effects.

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Analysis 8.4

Comparison 8 Midazolam IM versus diazepam IV, Outcome 4 Continuation of status requiring a different drug or general anaesthesia.

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Analysis 9.1

Comparison 9 Diazepam IV versus placebo IV, Outcome 1 Non‐cessation of seizures.

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Analysis 9.2

Comparison 9 Diazepam IV versus placebo IV, Outcome 2 Requirement for ventilatory support.

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Analysis 9.3

Comparison 9 Diazepam IV versus placebo IV, Outcome 3 Adverse effects.

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Analysis 9.4

Comparison 9 Diazepam IV versus placebo IV, Outcome 4 Continuation of status requiring a different drug or general anaesthesia.

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Analysis 9.5

Comparison 9 Diazepam IV versus placebo IV, Outcome 5 Death.

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Analysis 10.1

Comparison 10 Diazepam gel versus placebo gel, Outcome 1 Non‐cessation of seizures.

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Analysis 10.2

Comparison 10 Diazepam gel versus placebo gel, Outcome 2 Adverse effects.

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Analysis 11.1

Comparison 11 Diazepam 30 mg rectal versus diazepam 20 mg rectal, Outcome 1 Non‐cessation of seizures.

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Analysis 11.2

Comparison 11 Diazepam 30 mg rectal versus diazepam 20 mg rectal, Outcome 2 Adverse effects.

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Analysis 12.1

Comparison 12 Diazepam plus phenytoin IV versus phenobarbitone IV, Outcome 1 Non‐cessation of seizures.

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Analysis 12.2

Comparison 12 Diazepam plus phenytoin IV versus phenobarbitone IV, Outcome 2 Requirement for ventilatory support.

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Analysis 12.3

Comparison 12 Diazepam plus phenytoin IV versus phenobarbitone IV, Outcome 3 Adverse effects.

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Analysis 12.4

Comparison 12 Diazepam plus phenytoin IV versus phenobarbitone IV, Outcome 4 Death.

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Analysis 13.1

Comparison 13 Diazepam plus phenytoin IV versus phenobarbitone IV (premonitory status), Outcome 1 Non‐cessation of seizures.

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Analysis 14.1

Comparison 14 Diazepam plus phenytoin IV versus phenytoin IV, Outcome 1 Non‐cessation of seizures.

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Analysis 14.2

Comparison 14 Diazepam plus phenytoin IV versus phenytoin IV, Outcome 2 Adverse effects.

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Analysis 15.1

Comparison 15 Phenobarbitone IV versus phenytoin IV, Outcome 1 Non‐cessation of seizures.

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Analysis 15.2

Comparison 15 Phenobarbitone IV versus phenytoin IV, Outcome 2 Adverse effects.

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Table 1. Definitions of status epilepticus followed in various studies

Study	Definition
Alldredge 2002 (premonitory)	Continuous or repeated seizure activity > 5 minutes without recovery of consciousness.
Leppik 1983 (mixed)	(a) Generalised tonic‐clonic status: three or more generalised tonic‐clonic seizures in one hour; two or more generalised seizures in rapid succession without recovery of consciousness; (b) absence status: confusional state with generalised 3 Hz spike wave pattern on EEG; (c) complex partial status: confusional state, clinical seizure or both with focal EEG abnormality; (d) elementary status: partial seizures without loss of consciousness.
Pellock 1998 (premonitory)	Acute repetitive seizures (no definition).
Remy 1991 (mixed)	Successive partial seizures for at least 20 minutes or two generalised tonic‐clonic seizures within 20 minutes.
Shaner 1988 (established/mixed)	Generalised convulsive status epilepticus: (a) a history of 30 minutes of continuous generalised convulsive seizures and witnessed generalised seizures in the emergency room; (b) a history of 30 minutes of recurrent generalised convulsive seizures but failure to attain baseline mental status between seizures and witnessed generalised seizures in the emergency room; (c) a history of 3 or more generalised convulsive seizures in one hour in patients with obtundation prior to the onset of status epilepticus and witnessed generalised convulsive seizures in the emergency room; (d) uncertain history of seizures but generalised convulsive seizures continuously for more than 5 minutes as witnessed in the emergency room.
Singhi 2002 (refractory)	Motor seizures uncontrolled after 2 doses of diazepam and phenytoin infusion.
Mc Cormick 1999 (unclear)	No definition.
Chamberlain 1997 (premonitory)	Motor seizures of at least 10 minutes duration.
Appleton 1995 (unclear)	No definition.
Treiman 1998 (premonitory)	Overt generalised convulsive status: two or more generalised convulsions or continuous convulsive activity > 10 minutes.
Cereghino 2002 (premonitory)	Multiple seizures of complex partial or generalised type within an observation period between 12 ‐ 24 hours.

Table 1. Definitions of status epilepticus followed in various studies

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Comparison 1. Lorazepam IV versus diazepam IV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	3	264	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.45, 0.90]

2 Requirement for ventilatory support Show forest plot	3	264	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.36, 1.49]

3 Adverse effects Show forest plot	3	264	Risk Difference (M‐H, Fixed, 95% CI)	‐0.03 [‐0.10, 0.03]

4 Continuation of status requiring a different drug or general anaesthesia Show forest plot	3	264	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.45, 0.88]

5 Death Show forest plot	2	203	Risk Difference (M‐H, Fixed, 95% CI)	0.02 [‐0.04, 0.08]

Comparison 1. Lorazepam IV versus diazepam IV

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Comparison 2. Lorazepam IV versus placebo IV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.38, 0.71]

2 Requirement for ventilatory support Show forest plot	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.21, 1.07]

3 Adverse effects Show forest plot	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.21, 1.07]

4 Continuation of status requiring a different drug or general anaesthesia Show forest plot	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.38, 0.71]

5 Death Show forest plot	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.18, 1.33]

Comparison 2. Lorazepam IV versus placebo IV

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Comparison 3. Lorazepam IV versus diazepam plus phenytoin IV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	192	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.56, 1.13]

2 Adverse effects Show forest plot	1	192	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.63, 1.16]

Comparison 3. Lorazepam IV versus diazepam plus phenytoin IV

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Comparison 4. Lorazepam IV versus phenobarbitone IV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	188	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.58, 1.21]

2 Adverse effects Show forest plot	1	188	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.63, 1.16]

Comparison 4. Lorazepam IV versus phenobarbitone IV

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Comparison 5. Lorazepam IV versus phenytoin IV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.45, 0.86]

2 Adverse effects Show forest plot	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.72, 1.37]

Comparison 5. Lorazepam IV versus phenytoin IV

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Comparison 6. Midazolam IV versus lorazepam IV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	27	Risk Ratio (M‐H, Fixed, 95% CI)	0.2 [0.03, 1.56]

2 Requirement for ventilatory support Show forest plot	1	27	Risk Ratio (M‐H, Fixed, 95% CI)	0.4 [0.04, 3.90]

3 Adverse effects Show forest plot	1	27	Risk Ratio (M‐H, Fixed, 95% CI)	0.4 [0.04, 3.90]

4 Continuation of status requiring a different drug or general anaesthesia Show forest plot	1	27	Risk Ratio (M‐H, Fixed, 95% CI)	0.2 [0.03, 1.56]

Comparison 6. Midazolam IV versus lorazepam IV

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Comparison 7. Midazolam IV versus diazepam IV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	1.36 [0.25, 7.27]

2 Requirement for ventilatory support Show forest plot	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [0.59, 2.07]

3 Adverse effects Show forest plot	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.39, 1.66]

4 Death Show forest plot	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	3.62 [0.87, 14.97]

Comparison 7. Midazolam IV versus diazepam IV

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Comparison 8. Midazolam IM versus diazepam IV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	24	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.06, 12.01]

2 Requirement for ventilatory support Show forest plot	1	24	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.06, 12.01]

3 Adverse effects Show forest plot	1	24	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.06, 12.01]

4 Continuation of status requiring a different drug or general anaesthesia Show forest plot	1	24	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.06, 12.01]

Comparison 8. Midazolam IM versus diazepam IV

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Comparison 9. Diazepam IV versus placebo IV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.57, 0.92]

2 Requirement for ventilatory support Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.16, 0.94]

3 Adverse effects Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	0.46 [0.20, 1.04]

4 Continuation of status requiring a different drug or general anaesthesia Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.57, 0.92]

5 Death Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.08, 0.98]

Comparison 9. Diazepam IV versus placebo IV

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Comparison 10. Diazepam gel versus placebo gel

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	2	165	Risk Ratio (M‐H, Fixed, 95% CI)	0.43 [0.30, 0.62]

2 Adverse effects Show forest plot	2	165	Risk Ratio (M‐H, Fixed, 95% CI)	1.50 [0.94, 2.37]

Comparison 10. Diazepam gel versus placebo gel

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Comparison 11. Diazepam 30 mg rectal versus diazepam 20 mg rectal

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.18, 0.86]

2 Adverse effects Show forest plot	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.53, 1.53]

Comparison 11. Diazepam 30 mg rectal versus diazepam 20 mg rectal

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Comparison 12. Diazepam plus phenytoin IV versus phenobarbitone IV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	36	Risk Ratio (M‐H, Fixed, 95% CI)	4.0 [0.98, 16.30]

2 Requirement for ventilatory support Show forest plot	1	36	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.40, 2.52]

3 Adverse effects Show forest plot	2	222	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.77, 1.30]

4 Death Show forest plot	1	36	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.10, 0.10]

Comparison 12. Diazepam plus phenytoin IV versus phenobarbitone IV

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Comparison 13. Diazepam plus phenytoin IV versus phenobarbitone IV (premonitory status)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	186	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.76, 1.47]

Comparison 13. Diazepam plus phenytoin IV versus phenobarbitone IV (premonitory status)

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Comparison 14. Diazepam plus phenytoin IV versus phenytoin IV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	196	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.59, 1.04]

2 Adverse effects Show forest plot	1	196	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.86, 1.56]

Comparison 14. Diazepam plus phenytoin IV versus phenytoin IV

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Comparison 15. Phenobarbitone IV versus phenytoin IV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cessation of seizures Show forest plot	1	186	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.57, 1.06]

2 Adverse effects Show forest plot	1	186	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.81, 1.47]

Comparison 15. Phenobarbitone IV versus phenytoin IV

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