Electronic Thesis and Dissertation Repository

Thesis Format

Monograph

Degree

Master of Science

Program

Epidemiology and Biostatistics

Supervisor

Poonai, Naveen

2nd Supervisor

Speechley, Kathy N.

Co-Supervisor

Abstract

Medical procedures (e.g., intravenous insertion, laceration repair, diagnostic imaging, lumbar puncture) are often a source of distress in children. Intranasal midazolam (INM) is a commonly used anxiolytic, but there is no comprehensive summary of evidence to inform clinicians of its benefit across indications in children. Our objective was to evaluate the effectiveness of INM relative to any comparator for minimizing distress in children undergoing distressful or painful medical procedures through systematic review and meta-analysis. During intravenous insertions, laceration repairs, and diagnostic imaging, INM was more effective compared to placebo for reducing procedural distress and allowed adequate procedural completion with rare serious adverse events. There was insufficient evidence that INM was more effective relative to any comparator for reducing distress during intravenous insertion, laceration repair, diagnostic imaging, lumbar puncture, or bone marrow aspiration. More rigorously designed trials following official reporting guidelines and using validated measures of distress are needed.

Summary for Lay Audience

In the last few decades, there has been exponential growth in the number of non-invasive or minimally invasive medical procedures such as laceration repairs and diagnostic studies, performed outside of the operating room. These procedures are commonly used to assess and treat patients in medical settings such as emergency and outpatient departments. However, for children, these medical procedures have been shown to be frequent sources of distress. Unfortunately, such distress can lead to negative consequences such as lack of cooperation or excessive movements that can, in turn, interfere with the performance of these procedures. Therefore, adequately addressing such procedural distress has become one of the integral components to providing children with quality health care. To manage procedural distress, many pharmacological agents are available. Intranasal midazolam (INM) has become one of the most commonly used agents for pediatric pre-procedural anxiolysis. To ensure that the best drug is offered to patients in terms of safety and efficacy, it is essential to determine the effects of INM compared to other drugs. However, there is no comprehensive summary of evidence to inform clinicians regarding INM’s benefit across different medical procedures in children. The objective of this systematic review and meta-analysis was to address this knowledge gap by systematically identifying and evaluating available evidence on the effectiveness of INM relative to any other comparator for managing distress for medical procedures associated with pain or distress in children. A total of 51 studies were included in this review. Results showed that during intravenous insertions, laceration repairs, and diagnostic imaging, INM was more effective compared to placebo for reducing procedural distress and allowed adequate procedural completion with rare instances of apnea and no other serious adverse events. However, there was insufficient evidence to suggest that INM was more effective compared to any other comparator for reducing distress during intravenous insertion, laceration repair, diagnostic imaging, lumbar puncture, or bone marrow aspiration. There is a clear need for more rigorously designed clinical trials following official reporting guidelines and using validated tools to measure procedural distress.

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Available for download on Friday, June 27, 2025

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