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Intramuscular Versus Buccal Midazolam for Pediatric Seizures: A Randomized Double-Blinded Trial
Khalid Alansari1, Magda Barkat2, AbdelNasir H Mohamed2
1Department of Emergency Medicine, Sidra Medicine, Doha, Qatar; Weill Cornell Medicine - Qatar, Doha, Qatar.
Insights
Intramuscular midazolam is a favorable first-line treatment for pediatric seizures compared to buccal midazolam. This study found intramuscular midazolam to be more effective and safer for active seizures in children.
Area of Science:
- Emergency Medicine
- Pediatric Neurology
- Pharmacology
Background:
- Active seizures in children require prompt and effective first-line treatment.
- Midazolam is a commonly used medication for seizure management.
- Comparing different administration routes is crucial for optimizing pediatric emergency care.
Purpose of the Study:
- To compare the efficacy and safety of intramuscular versus buccal midazolam as first-line treatment for active seizures in pediatric patients.
- To evaluate seizure cessation rates, need for additional medication, seizure duration, and adverse events.
Main Methods:
- A double-blind, double-dummy randomized trial was conducted.
- 150 children with active seizures lasting over five minutes were enrolled.
- Primary outcome was seizure cessation within five minutes of drug administration; secondary outcomes included need for additional medication, seizure duration, and side effects.
Main Results:
- Seizure cessation occurred in 61% of the intramuscular group versus 46% of the buccal group (P=0.07).
- Fewer patients required additional anti-seizure treatment in the intramuscular group (39%) compared to the buccal group (51%).
- One patient in the intramuscular group experienced respiratory depression and hypotension; no side effects were attributed to buccal midazolam.
Conclusions:
- Intramuscular midazolam demonstrates favorable efficacy and safety compared to buccal midazolam for first-line treatment of pediatric seizures.
- Intramuscular administration may be a more effective route for rapid seizure control in children.
- Further research could explore optimal dosing and patient selection for each administration route.
Background:
We compared the efficacy and safety of intramuscular with buccal midazolam as first-line treatment for active seizures in children brought to the emergency department.
Methods:
In a double-blind, double-dummy randomized trial, patients with an active seizure lasting more than five minutes received blinded treatments on arrival. We employed deferred consent. The proportion of patients with cessation of seizure within five minutes of drug administration was the primary efficacy outcome; proportions needing additional medication to control seizure, duration of seizure activity, and side effects were secondary outcomes.
Results:
We enrolled 150 children presenting with active seizure, age range 4.5 to 167.5 months. Cessation of seizure occurred in 61% of the intramuscular and 46% of the buccal treatment groups, (P = 0.07, difference 15.5%, 95% confidence interval for the difference -1.0 to 32.0%). Proportions requiring additional anti-seizure treatment were 39% in the intramuscular and 51% in the buccal groups. Mean duration of seizure activity after administration of study medication was 15.9 minutes (S.D. 28.7) in the intramuscular and 17.8 minutes (S.D. 27.5) in the buccal group. One patient in the intramuscular group developed respiratory depression and hypotension; there were no side effects attributed to investigational treatment in the buccal group.
Conclusions:
Efficacy and safety of intramuscular midazolam as first-line treatment for pediatric seizures compare favorably to that of buccal midazolam.
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