| CTRI Number |
CTRI/2024/09/073174 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Comparing two different routes of administrating seizure drugs in children and check their efficacy and time of action |
|
Scientific Title of Study
|
Comparison between intranasal midazolam and intravenous
midazolam in children with seizures (randomised controlled study) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr TN MOHAMMED NADHEEM |
| Designation |
POST GRADUATE |
| Affiliation |
Sri manakula vinayagar medical college and hospita |
| Address |
No 49,department of paediatrics Sri manakula vinayagar medical college and hospital
Coimbatore
TAMIL NADU
641602
India |
| Phone |
9629225257 |
| Fax |
|
| Email |
nadheemtn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BHARATH KUMAR T |
| Designation |
HOD |
| Affiliation |
Sri manakula vinayagar medical college and hospita |
| Address |
Room no-49 Paediatric OPD Department of Paediatrics Sri
manakula vinayagar medical college and hospital,
Kalitheerthalkuppam, Madagadipet,Puducherry India
Pondicherry
PONDICHERRY
605107
India
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9003468873 |
| Fax |
|
| Email |
scooby_25575@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BHARATH KUMAR T |
| Designation |
Head of the Department |
| Affiliation |
Sri manakula vinayagar medical college and hospita |
| Address |
Room no-49 Paediatric OPD Department of Paediatrics Sri
manakula vinayagar medical college and hospital,
Kalitheerthalkuppam, Madagadipet,Puducherry India
Pondicherry
PONDICHERRY
605107
India
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9003468873 |
| Fax |
|
| Email |
scooby_25575@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room no-49 Paediatrics OPD, Department of paediatrics Sri
manakula vinayagar medical college and hospital,
Kalitheerthalkuppam,Madagadipet Puducherry,605107 |
|
|
Primary Sponsor
|
| Name |
TN MOHAMMED NADHEEM |
| Address |
NO.20 VENGADAPPA GOUNDER LAYOUT POSTAL COLONY,P.N ROAD SECOND STREET, TIRUPUR-641 602 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr TN MOHAMMED NADHEEM |
Sri manakula vinayagar medical college and hospital |
ROOM NO 49,PAEDIATRIC DIVISION ,DEPARTMENT OF PAEDIATRICS
Pondicherry
PONDICHERRY |
9629225257
nadheemtn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH-ETHICS COMMITTEE(ECR/685/Inst/PY/2014/RR-21 DT.30.12.2021 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F910||Conduct disorder confined to family context, (2) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRANASAL MIDAZOLAM VS INTRAVENOUS MIDAZOLAM |
Intra nasal midazolam ( Route-Intranasal) (Dose-0.2 mg/kg/dose),assessment - 3 minutes,if seizure does not aborts- second of intranasal ,if further seizure does not aborts———-Switch to Intravenous Midazolam(Dose-0.1 mg/kg/dose) ,assesment -2 minutes,if further seizure does not aborts go for second line Iv anti epilepticus |
| Comparator Agent |
INTRANASAL VS INTRAVENOUS |
INTRANASAL VS INTRAVENOUS |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children with acute seizure, febrile seizure, unprovoked seizure, provoked seizure,Children who are a known case of seizure disorder.
|
|
| ExclusionCriteria |
| Details |
Children with prolonged seizure(status epilepticus), Children‟s with renal diseases, Children with hypoglycemic seizures, hypocalcemic seizure, URI. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intranasal midazolam group –repeat one more dose of Intranasal midazolam-if at all
seizure does not abort the Principal Investigator should shift to Intravenous midazolam
routes.
|
2 MINS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intravenous midazolam - if seizure does not abort in first dose of Intravenous midazolam –
repeat one more dose of Intravenous midazolam . If at all seizure does not abort in Intranasal
group then the Principal Investigator should shift to second line Intravenous midazolam
antiepileptic‟s |
4 MINS |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective randomized controlled trial will be conducted in the casualty,picu, SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL after the approval of research committee and institutional ethics committee. Children in the age group of 6 months to 13 years presenting with acute seizures based on risk of recurrence, child was admitted in emergency department or pediatrics department ICU in SMVMCH fulfilling inclusion criteria will be considered for the study. Randomization technique will be used to select the intervention Group A(Intranasal midazolam ) and Group B (intravenous midazolam) to be given to the study participants. An online resource (www.sealedenvelope.com) will be used to create this block randomized list. The random list order of interventions will be printed in cards and kept in sealed envelopes in the order as in the list. Each envelope will be opened just before the procedure and the intervention which is written on the card will be administered. The list generated is attached as an annexure. The block randomization will be done in two study groups. Group A (Intranasal midazolam ) and Group B (Intravenous midazolam).The route of drugs given by two methods will re assessed at every 3-5 minutes . If Children not meeting the inclusion criteria will be excluded from the study |