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Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation

NCT02512783 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2016-07-21

Study results available
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Summary

This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.

Conditions

Interventions

DRUG

Lidocaine

Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation

DRUG

Normal Saline

Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation

DRUG

Propofol

Intravenous administration of propofol according to standard care to sedate patient.

Sponsors & Collaborators

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Principal Investigators

  • Didima Mon-Sprehe, MD · Children's Hospitals and Clinics of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02512783 on ClinicalTrials.gov