Status:
TERMINATED
Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.
Lead Sponsor:
Kamuzu University of Health Sciences
Conditions:
Status Epilepticus
Convulsions
Eligibility:
All Genders
2-15 years
Phase:
PHASE3
Brief Summary
This study aims to address the hypothesis that Lorazepam (an anticonvulsant) is as effective when given via the intranasal or buccal route as the intravenous route in terminating convulsions in childr...
Detailed Description
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 childhoo...
Eligibility Criteria
Inclusion
- children with acute generalized seizures, continuing for a minimum of 5 minutes, who have not received any anti-convulsant therapy within 1 hour of presentation.
Exclusion
- Children who have received anticonvulsant treatment within 1 hour prior to assessment. Any child whose seizures cease following correction of hypoglycaemia. Children with a known adverse reaction to lorazepam.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00343096
Start Date
June 1 2006
End Date
March 1 2009
Last Update
July 10 2012
Active Locations (1)
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1
Queen Elizabeth Central Hospital, Paediatric Dept, Box 360
Blantyre, Malawi, 3