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Completed

NCT Number: NCT02396537

Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This was a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department with an annual census of 67,000 patients. Children 6-12 years old for whom IN midazolam was ordered were eligible for enrollment. Patients were randomly assigned an identical intranasal medication (4% Lidocaine or 0.9% saline). Patients were administered the study drug followed by IN midazolam. Patients then assigned a pain score for midazolam administration using the Wong-Baker FACES Pain Rating scale. The primary endpoint of pain score was analyzed with a two-tailed Mann-Whitney U test, with P < 0.05 considered statistically significant.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine

Drug

Administered intranasally prior to Midazolam administration.

Other names: Xylocaine

midazolam

Drug

Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.

Other names: Versed

0.9% saline

Drug

Administered intranasally prior to Midazolam administration.

Primary outcomes

  1. Discomfort With Intranasal Midazolam Administration

    Time frame: immediately after administration of intranasal midazolam

    subject self-reports pain with intranasal midazolam utilizing the Wong-Baker FACES Pain Scale. This scale is a well-established ordinal pain scale for pediatric patients. It is one score (no subscales), with a minimum score of 0 (signifying "No Hurt") and a maximum score of 10 ("Hurts Worst"). Values between include 2 ("Hurts Little Bit"), 4 ("Hurts Little More"), 6 ("Hurts Even More"), and 8 ("Hurts Whole Lot."). Children indicate one value/answer. Thus, a higher score indicates a worse outcome (more pain).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration: A Double-blind, Randomized, Placebo-controlled Trial

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 24, 2015
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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