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
  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 Phase
Status Epilepticus
Convulsions
Drug: Lorazepam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

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.

Enrollment: 800
Study Start Date: June 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lorazepam
    All doses 0.1mg/kg once, repeat after 10 minutes x1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Elizabeth Molyneux, Professor of Paediatircs, University of Malawi College of Medicine
ClinicalTrials.gov Identifier: NCT00343096     History of Changes
Other Study ID Numbers: The BIVIN Trial
Study First Received: June 21, 2006
Last Updated: July 9, 2012
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:
Seizures
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lorazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 22, 2014