Comparing the Outcome of Buccal Midazolam and Intramuscular Midazolam in Children Presenting With Seizures.
NCT07626255 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-06-15
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.
Conditions
- Seizure Disorder Generalized Tonic Clonic
Interventions
- DRUG
-
Midazolam
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 & Collaborators
-
Pakistan Air Force (PAF) Hospital Islamabad
lead OTHER
Principal Investigators
-
Prof Dr Asma Shabbir, MBBS,FCPS(Paediatrics),MHPE · Pakistan Air Force Hospital Islamabad
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-15
- Primary Completion
- 2022-05-14
- Completion
- 2022-06-14
Countries
- Pakistan
Study Locations
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