Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396537
• Other study ID #: F130917005
• Status: Completed
• Phase: N/A
• First received: March 11, 2015
• Last updated: March 17, 2015
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine
Administered intranasally prior to Midazolam administration.
• Midazolam
Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.
• 0.9% Saline
Administered intranasally prior to Midazolam administration.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain felt during administration of Midazolam	Will evaluate the pain felt by each child after administration of Midazolam after pre-treatment with either Lidocaine or placebo utilizing a Wong-Baker FACES Pain Scale.	9 months	No