Intramuscular Midazolam Versus Intravenous Diazepam for Acute Seizure in Children

NCT06271096 | Completed Early Phase 1

• 1 other identifier: 638/ADR/KMC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Seizures

Outcome Measures

Primary Outcomes (1)

• Fits Controlled

  Treatment was considered successful if seizures stopped within 300 seconds of administering the drug. If seizures were not controlled within 300 seconds, Treatment failures were marked. other anticonvulsants were tried.

  300 seconds

Study Arms (2)

Group A IM-Midazolam

EXPERIMENTAL

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

Drug: Intra muscular Midazolam

Group B IV Diazepam

EXPERIMENTAL

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

Drug: Intravascular Diazepam

Interventions

Intra muscular Midazolam DRUG

ROUTE OF ADMINISTRATION AND DRUG EFFICACY COMPARED

Group A IM-Midazolam

Intravascular Diazepam DRUG

ROUTE OF ADMINISTRATION AND DRUG EFFICACY COMPARED

Group B IV Diazepam

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \. Children who already had intravenous access. 2. Children who had signs of clinical heart failure like tachycardia, tachypnea, and hepatomegaly.
• \. Children who had any severe systemic disease like renal disorder, liver disorder, and Beta Thalassemia major.
• \. 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

Sponsors & Collaborators

• Arooj Khan: lead

Study Sites (1)

Khyber Teaching Hospital

Peshawar, 25000, Pakistan

Location

Related Publications (8)

• Hosseini F, Nikkhah A, Afkhami Goli M. Serum Zinc Level in Children with Febrile Seizure. Iran J Child Neurol. 2020 Winter;14(1):43-47.

  PMID: 32021627 BACKGROUND

• Santillanes G, Luc Q. Emergency department management of seizures in pediatric patients. Pediatr Emerg Med Pract. 2015 Mar;12(3):1-25; quiz 26-7.

  PMID: 25799698 BACKGROUND

• Scott RC. What are the effects of prolonged seizures in the brain? Epileptic Disord. 2014 Oct;16 Spec No 1(Spec No 1):S6-11. doi: 10.1684/epd.2014.0689.

  PMID: 25323416 BACKGROUND

• Zilberter Y, Zilberter M. The vicious circle of hypometabolism in neurodegenerative diseases: Ways and mechanisms of metabolic correction. J Neurosci Res. 2017 Nov;95(11):2217-2235. doi: 10.1002/jnr.24064. Epub 2017 May 2.

  PMID: 28463438 BACKGROUND

• Kienitz R, Kay L, Beuchat I, Gelhard S, von Brauchitsch S, Mann C, Lucaciu A, Schafer JH, Siebenbrodt K, Zollner JP, Schubert-Bast S, Rosenow F, Strzelczyk A, Willems LM. Benzodiazepines in the Management of Seizures and Status Epilepticus: A Review of Routes of Delivery, Pharmacokinetics, Efficacy, and Tolerability. CNS Drugs. 2022 Sep;36(9):951-975. doi: 10.1007/s40263-022-00940-2. Epub 2022 Aug 16.

  PMID: 35971024 BACKGROUND

• 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.

  PMID: 23798902 BACKGROUND

• 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.

  PMID: 29443201 BACKGROUND

• 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.

  PMID: 32387007 BACKGROUND

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Muhammad Kashif

Model Details: This study was a randomized controlled trial carried out between November 2019 to November 2022 in the Pediatric department of Khyber Teaching Hospital. A total of 150 children who presented to the emergency department with seizures were enrolled in this study via consecutive sampling. This study was approved by the Ethical Review

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 21, 2024
• Study Start: November 1, 2019
• Primary Completion: November 1, 2022
• Study Completion: January 1, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

PA (1)