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A randomised controlled clinical trial to compare the effects of injectable sodium valproate with injectable phenytoin in children having acute seizures.

Comparison of Intravenous Valproate with Phenytoin in acute seziures in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/10/004081
Enrollment
134
Registered
2013-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- acute seizures

Interventions

Intervention1: Sodium Valproate: 20 mg /kg loading dose I/V followed by 20 mg / kg/ day maintainance dose in two divided doses for 1 day Control Intervention1: Phenytoin Sodium: 20 mg/kg/ loading dose

Sponsors

Department of PediatricsGovt Multispeciality hospital Sector Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Presenting with either of following : A clinical features of Motor seizures (generalized or focal ) in active stage at Pediatric Emergency , Patients with acute repetitive seizures ( two or more episodes of seizures in last 12 hours.

Exclusion criteria

Exclusion criteria: 1. 12 years 2. already on antiepileptic drugs 3. children with head trauma 4. very sick child with shock or impending respiratory failure. 5. Known hypersensitive to phenytoin/ Valproate 6. Known liver disease or clinically icteric.

Design outcomes

Primary

MeasureTime frame
Seizure control and recurrences of seizure for 24 hour period between the two groups Timepoint: Seizure control and recurrences of seizure for 24 hour period between the two groups

Secondary

MeasureTime frame
1. time taken to control seizures. 2. variation in cardiorespiratory parameters. 3. time to regain consciousness 4. any adverse effectsTimepoint: vital monitoring at admission, 15 min, 30 min, 1 hr, 6hr, 12 hr and 24 hr.

Countries

India

Contacts

Public ContactDr Ajeshwar Mahant

Govt Multispeciality hospital, sector 16

ndhawan_6144@yahoo.com9815629496

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026