Clinical trial NCT00343096: Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.
Official title: Buccal, Intranasal or Intravenous Lorazepam for the Treatment of Acute Convulsions in Children in Blantyre, Malawi: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Status Epilepticus
Convulsions
Keywords: intranasal
buccal
lorazepam
paediatric
convulsions
Lead sponsor: Kamuzu University of Health Sciences
Sponsor class: OTHER
First posted: 2006-06-22
Enrollment: 800
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Whether cessation of fit was achieved within ten minutes or not.
Secondary outcomes:
measure: Frequency of additional drugs required to terminate presenting seizure
measure: Frequency of cardio-respiratory side effects
measure: Seizure recurrence within 24 hours of terminating the presenting seizure
measure: Time from identification of a fitting child to cessation of fit.
measure: Outcome of patients including any neurological sequelae at hospital discharge.
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Queen Elizabeth Central Hospital, Paediatric Dept, Box 360
Study officials:
affiliation: College of Medicine
name: Elizabeth Molyneux
role: PRINCIPAL_INVESTIGATOR
References: