Comparing the Outcome of Buccal Midazolam and Intramuscular Midazolam in Children Presenting With Seizures.

Pakistan Air Force (PAF) Hospital Islamabad

Status and phase: Completed; Phase 4

Conditions: Seizure Disorder Generalized Tonic Clonic

Treatments: Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT07626255

ERC/15

Details and patient eligibility

About

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.

Full description

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.

Objectives:

To compare the outcome of buccal midazolam versus intramuscular midazolam in children presenting with seizures.

Study Design: Quasi experimental study

Settings: Pediatric Medicine Department, PAF hospital, Islamabad

Study Duration: 15th January 2022 to 14th July 2022

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.

Enrollment: 90 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 2 patient groups

Buccal Midazolam

Active Comparator group

Description:

In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml).

Treatment:

Drug: Midazolam

Intramuscular Midazolam

Active Comparator group

Description:

In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml)

Treatment:

Drug: Midazolam