Seizure Disorder Generalized Tonic Clonic
Conditions
Keywords
Acute seizure, Buccal midazolam, Intramuscular midazolam
Brief summary
The goal of this clinical trial(Quasi Experimental) is to compare efficacy of oral midazolam over intra-muscular Midazolam in children suffering from seizures. The main question it aims to answer is: Does Buccal midazolam has a better efficacy as compared to intramuscular midazolam in children presenting with seizures? There will be two groups determined by randomisation and then one will be given buccal midazolam and other will will be administered IM Midazolam .The out come will be determined by the determining the cessation of seizures within 5 minutes duration achieved by administration of drug.
Detailed description
1. Introduction: Generalised convulsive seizure is a serious and potentially life threatening medical emergency that requires prompt intervention. Administration of buccal midazolam is an efficient and easier method for control of seizures without the need for intravenous cannulation expertise or intramuscular injections. 2. Objectives: To compare the outcome of buccal midazolam versus intramuscular midazolam in children presenting with seizures. 3. Study Design: It is RCT 4. Settings: Pediatric Medicine Department, PAF hospital, Islamabad 5. Study Duration: 15th January 2022 to 14th July 2022 6\. Materials & Methods: A total of 90 patients of both genders, 6 months to 12 years of age, presenting with seizures were included. Children with cardiac arrest or haemodynamic instability at presentation, head trauma or drowning, metabolic disorders, CKD were excluded. All the patients were divided into two groups by lottery method. In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml). In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml). They were followed till resolution of symptoms. If seizure resolved within 5 minutes, then success was labelled.
Interventions
DRUGMidazolam
In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml). In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml).
Sponsors
Pakistan Air Force (PAF) Hospital Islamabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Children of age 6 months to 12 years, both genders, presenting with seizures (as per operational definition) 2. Children with Seizure disorder, Febrile fits, Meningitis without raised intracranial pressure.
Exclusion criteria
1. Children with cardiac arrest or hemodynamic instability at presentation, head trauma or drowning. 2. Diagnosed cases of metabolic disorders, CKD. 3. Diagnosed case of raised ICP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cessation of seizues | 5 minutes after drug administered | Cessation of seizures within 5 minutes duration achieved by administration of drug will be determined as success. Based on this cut off value for time we obtained dichotomous results i.e, Successful or Not Successful. 1. Seizures resolving \> 5 minutes considered unsuccessful. 2. Seizures resolving \< 5 minutes considered successful. |
Countries
Pakistan
Contacts
STUDY_CHAIRProf Dr Asma Shabbir, MBBS,FCPS(Paediatrics),MHPE
Pakistan Air Force Hospital Islamabad
Outcome results
None listed