Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.

Status Epilepticus Clinical Trial

Official title:

Buccal, Intranasal or Intravenous Lorazepam for the Treatment of Acute Convulsions in Children in Blantyre, Malawi: a Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00343096
• Other study ID #: The BIVIN Trial
• Status: Terminated
• Phase: Phase 3
• First received: June 21, 2006
• Last updated: July 9, 2012
• Start date: June 2006
• Est. completion date: March 2009

Study information

• Verified date: July 2012
• Source: University of Malawi College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 800
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 15 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Convulsions
• Seizures
• Status Epilepticus

Intervention

Drug:
• Lorazepam
All doses 0.1mg/kg once, repeat after 10 minutes x1

Locations

Country	Name	City	State
Malawi	Queen Elizabeth Central Hospital, Paediatric Dept, Box 360	Blantyre

Sponsors (1)

Lead Sponsor	Collaborator
University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether cessation of fit was achieved within ten minutes or not.
Secondary	Frequency of additional drugs required to terminate presenting seizure
Secondary	Frequency of cardio-respiratory side effects
Secondary	Seizure recurrence within 24 hours of terminating the presenting seizure
Secondary	Time from identification of a fitting child to cessation of fit.
Secondary	Outcome of patients including any neurological sequelae at hospital discharge.