Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.

This study has been 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)
Sponsor:
Information provided by (Responsible Party):
Elizabeth Molyneux, University of Malawi College of Medicine
ClinicalTrials.gov Identifier:
NCT00343096
First received: June 21, 2006
Last updated: July 9, 2012
Last verified: July 2012

June 21, 2006
July 9, 2012
June 2006
March 2009   (final data collection date for primary outcome measure)
Whether cessation of fit was achieved within ten minutes or not.
Same as current
Complete list of historical versions of study NCT00343096 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Status Epilepticus
  • Convulsions
Drug: Lorazepam
All doses 0.1mg/kg once, repeat after 10 minutes x1
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
800
March 2009
March 2009   (final data collection date for primary outcome measure)

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.

Both
2 Months to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT00343096
The BIVIN Trial
Not Provided
Elizabeth Molyneux, University of Malawi College of Medicine
University of Malawi College of Medicine
Not Provided
Principal Investigator: Elizabeth Molyneux College of Medicine
University of Malawi College of Medicine
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP