Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus

NCT ID: NCT04829838

Last Updated: 2021-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-25

Study Completion Date

2021-07-26

Brief Summary

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The purpose of studyis to compare the efficacy of phenytoin with levetiracetam for the management of children with status epilepticus.Study performa consists of demographic variables,exclusion criteria,history of epilepsy and efficacy achieved or not.

Detailed Description

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After getting informed consent 244 children with status epilepticus will be randomly classified into two groups.one group will receive levetireacetam and other group will be given phenytoin and their efficacy will be compared by observing them for breakthrough fits for next 48 hours.

Conditions

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Status Epilepticus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intravenous levetireacetam

Drug:Intravenous levetireacetam will be given at a loading dose of 20-30mg/kg then it will be added in maintainance dose of (5-30mg/kg/day)

Group Type EXPERIMENTAL

intravenous levetireacetam

Intervention Type DRUG

phenytoin is considered as control drug in the study

intravenous phenytoin

Intravenous phenytoin will be given in loading dose of 20mg/kg then it will be added in maintainance dose i-e 5-8mg/kg/day

Group Type EXPERIMENTAL

intravenous levetireacetam

Intervention Type DRUG

phenytoin is considered as control drug in the study

Interventions

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intravenous levetireacetam

phenytoin is considered as control drug in the study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* childen of age less than 12 years either gender admitted in pediatric emergency with status epilepticus

Exclusion Criteria

* children already taking either of trial drug or failed treatment with either of trial drug.children with comorbid conditions
Minimum Eligible Age

2 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Edward Medical University

OTHER

Sponsor Role collaborator

ayesha tariq

OTHER

Sponsor Role lead

Responsible Party

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ayesha tariq

Post graduate resident in Pediatrics medicine(MD Paeds)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Haroon Hamid, MBBS,FCPS

Role: PRINCIPAL_INVESTIGATOR

King Edward Medical University

Locations

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Ayesha Tariq

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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ayesha tariq, MBBS

Role: CONTACT

0923360495413

mohammad Haroon Hamid, MBBS,FCPS

Role: CONTACT

0923008880916

Facility Contacts

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ayesha tariq, MBBS

Role: primary

0923360495413

References

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Smith DM, McGinnis EL, Walleigh DJ, Abend NS. Management of Status Epilepticus in Children. J Clin Med. 2016 Apr 13;5(4):47. doi: 10.3390/jcm5040047.

Reference Type BACKGROUND
PMID: 27089373 (View on PubMed)

Abend NS, Loddenkemper T. Pediatric status epilepticus management. Curr Opin Pediatr. 2014 Dec;26(6):668-74. doi: 10.1097/MOP.0000000000000154.

Reference Type BACKGROUND
PMID: 25304961 (View on PubMed)

Other Identifiers

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700/RC/KEMU

Identifier Type: -

Identifier Source: org_study_id

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