A randomised controlled clinical trial to compare the effects of injectable sodium valproate with injectable phenytoin in children having acute seizures.
Phase 4
- Conditions
- Health Condition 1: null- acute seizures
- Registration Number
- CTRI/2013/10/004081
- Lead Sponsor
- Department of PediatricsGovt Multispeciality hospital Sector Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 134
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
1. <2 years and >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seizure control and recurrences of seizure for 24 hour period between the two groups <br/ ><br> <br/ ><br>Timepoint: Seizure control and recurrences of seizure for 24 hour period between the two groups <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. time taken to control seizures. <br/ ><br>2. variation in cardiorespiratory parameters. <br/ ><br>3. time to regain consciousness <br/ ><br>4. any adverse effectsTimepoint: vital monitoring at admission, 15 min, 30 min, 1 hr, 6hr, 12 hr and 24 hr.