Intramuscular Midazolam Versus Intravenous Diazepam for Acute Seizure in Children

NCT ID: NCT06271096

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2024-01-01

Brief Summary

IM-midazolam in acute seizures, whenever IV cannulation is not possible. It is easy to administer and can be used in prehospital settings as IV cannulation requires experience, especially in pediatric age group. Moreover, the transit time to the hospital can be prolonged in our areas which can delay the treatment if intravenous cannulation is considered. More studies are required to assess the feasibility of administering IM-midazolam in a prehospital setting to control acute seizures

Detailed Description

A seizure or convulsion is a time-limited, paroxysmal, change in motor activity and or behavior that results from electrical activity in the brain that is abnormal.1 The emergency department of a hospital is usually the place where children with seizures receive first treatment and medical support. Seizures make up about 1% of all emergency department visits for pediatric patients, and at least 5% of pediatric patients will have a seizure by the time they are 16 years old. Children younger than one year of age are commonly affected by new and unprovoked seizures.2 Seizures can result in continuous muscular activity, which leads to tissue breakdown because of anaerobic metabolism as well as decreasing oxygen and glucose to the brain causing brain ischemia and neuronal death. So, the seizures must be controlled rapidly to decrease the systemic as well as brain damage.3,4 First-line anticonvulsants for the treatment of acute seizures are benzodiazepines. Diazepam is frequently used for the treatment of seizures because it can be delivered either intravenously or rectally. It is lipophilic so does not have proper intramuscular absorption. Precious time is spent in getting intravenous access or per rectal catheterization. While midazolam, is a lipid-soluble benzodiazepine, rapidly absorbed after intramuscular (IM) injection.5,6 For managing seizure, the drug should be sufficiently potent to allow small volume and an administration that is quick, easy, and safe with quick action and little monitoring.7 Intramuscular midazolam meets these criteria and may be useful for the treatment of seizures, but more trials are needed to see the safety and efficacy of this therapy in the pediatric population.8 A major chunk of the seizures may occur out of the hospital. For the parents its frightening to see their kid in fits. Usually these parents immediately take their child to the nearby hospital or clinic. But it's not possible for all the parents, because in many areas health facilities are not present. Hence these patients are at increased risk for sustaining post ictal brain damage. There is a long-awaited wish that how to prevent this brain damage. A lot of options are tried nowadays and also in the past, like rectal diazepam, sublingual midazolam, but unfortunately most such options are not without risks.

The objective of this study was to compare the time taken by intramuscular midazolam to stop the seizure as compared to intravenous diazepam in emergency cases in the pediatric age group.

Conditions

Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A IM-Midazolam

Group A received IM midazolam at a dose of 0.2 mg/kg gently injected into the vastus lateralis muscle

Group Type: EXPERIMENTAL

Intra muscular Midazolam

Intervention Type: DRUG

ROUTE OF ADMINISTRATION AND DRUG EFFICACY COMPARED

Group B IV Diazepam

Patients in group B were cannulated in the dorsum of the hand or foot, or the great saphenous vein at the ankle first and then administered diazepam at a dose of 0.2mg/kg

Group Type: EXPERIMENTAL

Intravascular Diazepam

Intervention Type: DRUG

ROUTE OF ADMINISTRATION AND DRUG EFFICACY COMPARED

Interventions

Intra muscular Midazolam

ROUTE OF ADMINISTRATION AND DRUG EFFICACY COMPARED

Intervention Type: DRUG

Intravascular Diazepam

ROUTE OF ADMINISTRATION AND DRUG EFFICACY COMPARED

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients presented to the pediatric emergency, with all types of seizures, aged 3 months to 5 years.

Exclusion Criteria

• 1. Children who already had intravenous access. 2. Children who had signs of clinical heart failure like tachycardia, tachypnea, and hepatomegaly.

3. Children who had any severe systemic disease like renal disorder, liver disorder, and Beta Thalassemia major.

4. Known allergy to midazolam or diazepam 5. Children who had hypoglycemia as the known cause of seizure 6. Children with other known causes of fits, like hypocalcemia, CKD, Hypoparathyroidism, Renal Tubular Acidosis

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arooj Khan

OTHER

Sponsor Role: lead

Responsible Party

Arooj Khan

Assistant Professor Muhammad Kashif

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Khyber Teaching Hospital

Peshawar, , Pakistan

Countries

Pakistan

References

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Reference Type: BACKGROUND

PMID: 35971024 (View on PubMed)

Humphries LK, Eiland LS. Treatment of acute seizures: is intranasal midazolam a viable option? J Pediatr Pharmacol Ther. 2013 Apr;18(2):79-87. doi: 10.5863/1551-6776-18.2.79.

Reference Type: BACKGROUND

PMID: 23798902 (View on PubMed)

Agarwal SK, Cloyd JC. Development of benzodiazepines for out-of-hospital management of seizure emergencies. Neurol Clin Pract. 2015 Feb;5(1):80-85. doi: 10.1212/CPJ.0000000000000099.

Reference Type: BACKGROUND

PMID: 29443201 (View on PubMed)

Alansari K, Barkat M, Mohamed AH, Al Jawala SA, Othman SA. Intramuscular Versus Buccal Midazolam for Pediatric Seizures: A Randomized Double-Blinded Trial. Pediatr Neurol. 2020 Aug;109:28-34. doi: 10.1016/j.pediatrneurol.2020.03.011. Epub 2020 Mar 16.

Reference Type: BACKGROUND

PMID: 32387007 (View on PubMed)

Other Identifiers

638/ADR/KMC

Identifier Type: -

Identifier Source: org_study_id