Study Stopped
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
Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.
Buccal, Intranasal or Intravenous Lorazepam for the Treatment of Acute Convulsions in Children in Blantyre, Malawi: a Randomized Trial
1 other identifier
interventional
800
1 country
1
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 children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2006
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 21, 2006
CompletedFirst Posted
Study publicly available on registry
June 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJuly 10, 2012
July 1, 2012
2.8 years
June 21, 2006
July 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Whether cessation of fit was achieved within ten minutes or not.
Secondary Outcomes (5)
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.
Interventions
All doses 0.1mg/kg once, repeat after 10 minutes x1
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Elizabeth Central Hospital, Paediatric Dept, Box 360
Blantyre, 3, Malawi
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Molyneux
College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Paediatircs
Study Record Dates
First Submitted
June 21, 2006
First Posted
June 22, 2006
Study Start
June 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
July 10, 2012
Record last verified: 2012-07