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Childhood Convulsive Status Epilepticus Management In A Resource Limited Setting

NCT03650270 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2018-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Pediatric Status Epilepticus

Interventions

DRUG

Phenobarbital

Three repeated doses of pareneteral phenobarbital was compared to a single parenteral infusion of phenytoin followed by an infusion of parenteral midazolam

Sponsors & Collaborators

  • University of Cape Town

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-01
Primary Completion
2018-03-01
Completion
2018-03-01

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03650270 on ClinicalTrials.gov