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Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.
This study has been terminated.
( The buccal arm of the study was 30% less effecrtive in stopping seizures within 10 minutes compared with the IV dose. This met a stoppimg rule for the study )
First Received: June 21, 2006   Last Updated: March 12, 2008   History of Changes
Sponsor: University of Malawi College of Medicine
Information provided by: University of Malawi College of Medicine
ClinicalTrials.gov Identifier: NCT00343096
  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 Intervention
Status Epilepticus
Convulsions
Drug: Mode of administration - buccal, intranasal or intravenous

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Buccal, Intranasal or Intravenous Lorazepam for the Treatment of Acute Convulsions in Children in Blantyre, Malawi: a Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Malawi College of Medicine:

Primary Outcome Measures:
  • Whether cessation of fit was achieved within ten minutes or not.

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.

Estimated Enrollment: 1200
Study Start Date: June 2006
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   2 Months to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343096

Locations
Malawi
Queen Elizabeth Central Hospital, Paediatric Dept, Box 360
Blantyre, Malawi, 3
Sponsors and Collaborators
University of Malawi College of Medicine
Investigators
Principal Investigator: Elizabeth Molyneux College of Medicine
  More Information

No publications provided

Responsible Party: College of Medicine, Malawi ( Prof E Molyneux )
Study ID Numbers: The BIVIN Trial
Study First Received: June 21, 2006
Last Updated: March 12, 2008
ClinicalTrials.gov Identifier: NCT00343096     History of Changes
Health Authority: Malawi: College of Medicine Research and Ethics Committee

Keywords provided by University of Malawi College of Medicine:
intranasal
buccal
lorazepam
paediatric
convulsions

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Brain Diseases
Lorazepam
Signs and Symptoms
Status Epilepticus
Therapeutic Uses
Hypnotics and Sedatives
Tranquilizing Agents
Nervous System Diseases
Seizures
Gastrointestinal Agents
Central Nervous System Depressants
Central Nervous System Diseases
Pharmacologic Actions
Epilepsy
Autonomic Agents
Neurologic Manifestations
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010