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Childhood Convulsive Status Epilepticus Management In A Resource Limited Setting

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ClinicalTrials.gov Identifier: NCT03650270
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Jo M Wilmshurst, University of Cape Town

Brief 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.


Condition or disease Intervention/treatment Phase
Pediatric Status Epilepticus Drug: Phenobarbital Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: random allocation to 2 study protocols
Masking: Single (Outcomes Assessor)
Masking Description: The specific treatment protocol was blinded to the data analyser
Primary Purpose: Treatment
Official Title: Childhood Convulsive Status Epilepticus - In Search Of Optimal Drug Management In A Resource Limited Setting
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018


Arm Intervention/treatment
Experimental: Phenobarbital
If allocated to this arm 'Phenobarbital' (PHB group), the clinician gives an IV bolus of phenobarbital (20mg/kg ). If CSE did not terminate after 5 - 10 minutes, a second dose is given at half the dosage (10mg/kg) and a third dose (10mg/kg) is given if CSE persists 5-10 minutes after that.
Drug: Phenobarbital
Three repeated doses of pareneteral phenobarbital was compared to a single parenteral infusion of phenytoin followed by an infusion of parenteral midazolam
Other Names:
  • Phenytoin
  • Midazolam

Active Comparator: Phenytoin / Midazolam infusion
In the 'Phenytoin / Midazolam infusion' (PHY/MDZ group), children are given a dose (20mg/kg) of IV phenytoin mixed with 50mL of normal saline solution and administered over 30 minutes . If the child is still in CSE 5-10 minutes after the phenytoin is given, they then start on a midazolam infusion. This includes a loading dose of IV midazolam (0.2mg/kg) followed by an infusion set at 3mg/kg into 50mL 5% dextrose water given at a rate of 1-4 mL/hour (equivalent to 1-4 mcg/kg/min ).
Drug: Phenobarbital
Three repeated doses of pareneteral phenobarbital was compared to a single parenteral infusion of phenytoin followed by an infusion of parenteral midazolam
Other Names:
  • Phenytoin
  • Midazolam




Primary Outcome Measures :
  1. Differences in anticonvulsant efficacy between different second-line anticonvulsant treatment protocols [ Time Frame: Up to 24 hours from the time the patient was admitted. ]
    Assessing the time taken to reach seizure arrest after second-line agents given


Secondary Outcome Measures :
  1. Differences in how patients tolerate each of the two second-line anticonvulsant treatment protocols [ Time Frame: Up to 24 hours from the time the patient was admitted. ]
    Assessing differences physiological response to second-line anticonvulsant protocols

  2. Differences in need for pediatric intensive care between the two second-line anticonvulsant protocols [ Time Frame: Up to 24 hours from the time the patient was admitted. ]
    Assessing differences in proportion of patients who received second-line anticonvulsant therapy and then require admission to the pediatric intensive care unit

  3. Differences in admission time between patients who receive on of the two second-line anticonvulsant protocols [ Time Frame: For the full duration the patient is admitted, which on average is up to one full week (seven days). ]
    Assessing differences in the number of days the patient is admitted following admission



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Ages Eligible for Study:   1 Month to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children in convulsive status epilepticus (as defined by Trinka et al 2015)

Exclusion Criteria:

  • Children not in convulsive status epilepticus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650270


Locations
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South Africa
Red Cross War Memorial Children's Hospital
Cape Town, Western Cape, South Africa, 7700
Sponsors and Collaborators
University of Cape Town

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jo M Wilmshurst, Head of Department of Paediatric Neurology, Red Cross War Memorial Childrens Hospital, University of Cape Town
ClinicalTrials.gov Identifier: NCT03650270     History of Changes
Other Study ID Numbers: 297/2005
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We are exploring what data would of use

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Phenytoin
Status Epilepticus
Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Midazolam
Phenobarbital
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents