Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.

Condition(s) targeted: Status Epilepticus; Convulsions

Intervention: Mode of administration - buccal, intranasal or intravenous (Drug)

Phase: N/A

Status: Terminated

Sponsored by: University of Malawi College of Medicine

Official(s) and/or principal investigator(s):
Elizabeth Molyneux, Principal Investigator, Affiliation: College of Medicine

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Whether cessation of fit was achieved within ten minutes or not.

Secondary outcome:

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.

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.

Minimum age: 2 Months. Maximum age: 15 Years. Gender(s): Both.

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.

Queen Elizabeth Central Hospital, Paediatric Dept, Box 360, Blantyre 3, Malawi

Starting date: June 2006
Ending date: March 2009
Last updated: March 12, 2008