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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07626255 on ClinicalTrials.gov