A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children
Sponsor study identifier
interventional
156
1 country
1
Study Start
July 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
The purpose of this study is to evaluate intranasal lorazepam in paediatric status epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common paediatric medical emergency compared to our present first line therapy intramuscular paraldehyde.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2004
Date type not reportedThis date has not been verified as actual or estimated.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
June 26, 2005
Actual (reported)June 27, 2005
Actual (reported)whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration
time from drug administration to cessation of convulsion
frequency of episodes requiring 2 or more anticonvulsant agents
continuous blood pressure and oxygen saturation for 30 minutes post drug administration
seizure recurrence within 24 hours of cessation of presenting convulsion
survival/death
Paediatric Emergency Department, Queen Elizabeth Central Hospital
Blantyre, Malawi
Ahmad S, Ellis JC, Kamwendo H, Molyneux E. Efficacy and safety of intranasal lorazepam versus intramuscular paraldehyde for protracted convulsions in children: an open randomised trial. Lancet. 2006 May 13;367(9522):1591-7. doi: 10.1016/S0140-6736(06)68696-0.
Elizabeth Molyneux, MRCPCH FFAEM
Kamuzu University of Health Sciences
Shafique Ahmad, MRCPCH FFAEM
Kamuzu University of Health Sciences
First Submitted
June 26, 2005
First Posted
June 27, 2005
Study Start
July 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
June 2005
Date type not reportedPhase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus
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This date has not been verified as actual or estimated.
Last Updated
July 21, 2006
Record last verified: 2005-06
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Source: ClinicalTrials.gov.
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