Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.

Sponsor

University of Malawi College of Medicine (Other)

Overall Status

Terminated

CT.gov ID

NCT00343096

Collaborator

(none)

800

Enrollment

Location

Duration (Months)

24.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jun 1, 2006

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.