N/A
Completed N=77
Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration
Source: ClinicalTrials.gov NCT02396537 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Discomfort With Intranasal Midazolam Administration — 3; 8 units on a scale
Summary
The purpose of this study was to establish whether premedication with topical lidocaine would reduce the pain associated with IN midazolam administration in children. The study was designed to be a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Discomfort With Intranasal Midazolam Administration |
3; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Ages 6-12
- Previously healthy
- Attending physician concludes that the patient would benefit from administration of an anxiolysis medication prior to a minor procedure
Exclusion Criteria
- Moderate to severe asthma or other chronic lung disease
- Co-morbid conditions including cerebral palsy, developmental delay, or other chronic illness deemed by the Attending physician to be unsafe to receive anxiolysis with Versed.
- Any child presenting with a life-threatening condition.
Data sourced from ClinicalTrials.gov (NCT02396537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.