Pediatric Status Epilepticus Clinical Trial
Official title:
Childhood Convulsive Status Epilepticus - In Search Of Optimal Drug Management In A Resource Limited Setting
Verified date | August 2018 |
Source | University of Cape Town |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Convulsive status epilepticus (CSE) is a potentially devastating condition which can result
in significant morbidity and mortality. Studies addressing status epilepticus in children are
rare and there is a paucity of large randomised controlled trials in children looking at
forms of drug treatment for SE. There is consistency worldwide in guidelines for first line
treatment of CSE with benzodiazepines, with slight variations in type and route of
administration of agents. Second line therapy usually entails phenobarbital or phenytoin
parenterally. Both repeated phenobarbital loading doses and midazolam infusions have been
shown to be effective and safe in the management of established convulsive SE, but there are
no prospective randomized controlled trials comparing the two in children.
Our study has been undertaken to review 2 existing, and routinely used, interventions for
children presenting to our center with acute convulsive seizures. In order to permit
comparable data to be collected we are randomly allocating these standard interventions
prospectively. This is in order to compare the efficacy and safety of two treatment protocols
(phenobarbital vs phenytoin and midazolam) both of which as stated are already part of
existing standard protocols internationally and in South Africa. Parenteral phenobarbital is
a safe, affordable and easy to use drug in the management of status epilepticus especially
for poorly resourced communities where undertaking infusions may be unsafe, time consuming or
unavailable.
We hypothesize that repeated phenobarbital loading is as effective and safe, or more so, than
phenytoin followed by midazolam infusion in the management of established and refractory
childhood convulsive SE. If proven, then the former would be a viable option for all health
care workers with access to intravenous routes (including Day hospitals) where infusions are
unsafe, time consuming or unavailable.
Status | Completed |
Enrollment | 198 |
Est. completion date | March 1, 2018 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 15 Years |
Eligibility |
Inclusion Criteria: - Children in convulsive status epilepticus (as defined by Trinka et al 2015) Exclusion Criteria: - Children not in convulsive status epilepticus |
Country | Name | City | State |
---|---|---|---|
South Africa | Red Cross War Memorial Children's Hospital | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
University of Cape Town |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in anticonvulsant efficacy between different second-line anticonvulsant treatment protocols | Assessing the time taken to reach seizure arrest after second-line agents given | Up to 24 hours from the time the patient was admitted. | |
Secondary | Differences in how patients tolerate each of the two second-line anticonvulsant treatment protocols | Assessing differences physiological response to second-line anticonvulsant protocols | Up to 24 hours from the time the patient was admitted. | |
Secondary | Differences in need for pediatric intensive care between the two second-line anticonvulsant protocols | Assessing differences in proportion of patients who received second-line anticonvulsant therapy and then require admission to the pediatric intensive care unit | Up to 24 hours from the time the patient was admitted. | |
Secondary | Differences in admission time between patients who receive on of the two second-line anticonvulsant protocols | Assessing differences in the number of days the patient is admitted following admission | For the full duration the patient is admitted, which on average is up to one full week (seven days). |