Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children. | RxWiki

Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Status Epilepticus Convulsions
Intervention	Drug: Lorazepam
Phase	Phase 3
Sponsor	University of Malawi College of Medicine
Responsible Party	University of Malawi College of Medicine
ClinicalTrials.gov Identifier	NCT00343096
First Received	June 21, 2006
Last Updated	July 9, 2012
Last verified	July 2012

Tracking Information[ + expand ][ + ]

First Received Date	June 21, 2006
Last Updated Date	July 9, 2012
Start Date	June 2006
Estimated Primary Completion Date	March 2009
Current Primary Outcome Measures	Whether cessation of fit was achieved within ten minutes or not.
Current Secondary Outcome Measures	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.

Descriptive Information[ + expand ][ + ]

Brief Title	Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.
Official Title	Buccal, Intranasal or Intravenous Lorazepam for the Treatment of Acute Convulsions in Children in Blantyre, Malawi: a Randomized Trial
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.
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 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
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Status Epilepticus Convulsions
Intervention	Drug: Lorazepam All doses 0.1mg/kg once, repeat after 10 minutes x1
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	800
Estimated Completion Date	March 2009
Estimated Primary Completion Date	March 2009
Eligibility Criteria	Inclusion Criteria: 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 Criteria: 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.
Gender	Both
Ages	2 Months
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Malawi

Administrative Information[ + expand ][ + ]

NCT Number	NCT00343096
Other Study ID Numbers	The BIVIN Trial
Has Data Monitoring Committee	Not Provided
Information Provided By	University of Malawi College of Medicine
Study Sponsor	University of Malawi College of Medicine
Collaborators	Not Provided
Investigators	Principal Investigator: Elizabeth Molyneux College of Medicine
Verification Date	July 2012

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