Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.
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|ClinicalTrials.gov Identifier: NCT00343096|
Recruitment Status : Terminated (The buccal arm of the study was 30% less effective in stopping seizures within 10 minutes compared with the IV dose. This met a stopping rule for the study)
First Posted : June 22, 2006
Last Update Posted : July 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Status Epilepticus Convulsions||Drug: Lorazepam||Phase 3|
Convulsions are common in children. Prompt treatment with an effective anticonvulsant reduces longterm morbidity and mortality. The use of intravenous lorazepam as first line therapy in acute childhood convulsions where venous access has been obtained is widely accepted in developed countries. However, intravenous access can be a problem out of hospital or in small children.
Benzodiazepines such as Lorazepam have long been the mainstay of first line therapy for acute convulsions but there is insufficient clinical evidence as to the optimal mode of administration when venous access has failed. Lorazepam can be given via the intranasal and buccal route offering the potential to be as effective as intravenous lorazepam whilst being easier to administer and avoiding the need for intravenous cannulation.
To date there are no large published studies that have evaluated the efficacy and safety of intranasal or buccal lorazepam compared to intravenous lorazepam in the treatment of acute convulsions. In this study we wish to address the urgent need to obtain randomized controlled data in treating acute convulsions in children using a drug and delivery system that is safe, effective and easy to use in our setting.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||800 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Buccal, Intranasal or Intravenous Lorazepam for the Treatment of Acute Convulsions in Children in Blantyre, Malawi: a Randomized Trial|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
- Drug: Lorazepam
All doses 0.1mg/kg once, repeat after 10 minutes x1
- Whether cessation of fit was achieved within ten minutes or not.
- Frequency of additional drugs required to terminate presenting seizure
- Frequency of cardio-respiratory side effects
- Seizure recurrence within 24 hours of terminating the presenting seizure
- Time from identification of a fitting child to cessation of fit.
- Outcome of patients including any neurological sequelae at hospital discharge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343096
|Queen Elizabeth Central Hospital, Paediatric Dept, Box 360|
|Blantyre, Malawi, 3|
|Principal Investigator:||Elizabeth Molyneux||College of Medicine|