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Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.

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ClinicalTrials.gov Identifier: NCT00343096
Recruitment Status : 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)
First Posted : June 22, 2006
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Elizabeth Molyneux, University of Malawi College of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Status Epilepticus Convulsions Drug: Lorazepam Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buccal, Intranasal or Intravenous Lorazepam for the Treatment of Acute Convulsions in Children in Blantyre, Malawi: a Randomized Trial
Study Start Date : June 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Lorazepam

Arms and Interventions
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Intervention Details:
  • Drug: Lorazepam
    All doses 0.1mg/kg once, repeat after 10 minutes x1

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

Secondary Outcome Measures :
  1. Frequency of additional drugs required to terminate presenting seizure
  2. Frequency of cardio-respiratory side effects
  3. Seizure recurrence within 24 hours of terminating the presenting seizure
  4. Time from identification of a fitting child to cessation of fit.
  5. Outcome of patients including any neurological sequelae at hospital discharge.

Eligibility Criteria
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Ages Eligible for Study:   2 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343096


Locations
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Malawi
Queen Elizabeth Central Hospital, Paediatric Dept, Box 360
Blantyre, Malawi, 3
Sponsors and Collaborators
University of Malawi College of Medicine
Investigators
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Principal Investigator: Elizabeth Molyneux College of Medicine
More Information
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Responsible Party: Elizabeth Molyneux, Professor of Paediatircs, University of Malawi College of Medicine
ClinicalTrials.gov Identifier: NCT00343096    
Other Study ID Numbers: The BIVIN Trial
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012
Keywords provided by Elizabeth Molyneux, University of Malawi College of Medicine:
intranasal
buccal
lorazepam
paediatric
convulsions
Additional relevant MeSH terms:
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Status Epilepticus
Seizures
Neurologic Manifestations
Nervous System Diseases
Lorazepam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action