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Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children

NCT00521703 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2008-05-23

No results posted yet for this study

Summary

There is some controversy in the medical literature regarding the effectiveness of topical lidocaine in children as an adjuvant drug to upper gastrointestinal endoscopy. In children, deep sedation and general anesthesia are often used to sedate children submitting to this procedure. Propofol is an anesthetic drug increasingly popular in this situation, but this drug can only be used with an anesthesiologist in Brazil. Its main side effects include hypotension, respiratory depression and local pain. Lidocaine is frequently used as premedication, and the rationale is that lowering patient discomfort could lower the required dose to achieve the endoscopy and reduce potential side effects. Nevertheless, some patients perceive this medication as uncomfortable. This study aims to compare sedative drug doses between patients who were given either placebo or topical lidocaine.

Conditions

  • Dyspepsia
  • Malabsorption Syndrome
  • Gastroesophageal Reflux Disease
  • Abdominal Pain

Interventions

DRUG

Lidocaine

oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing

DRUG

Tannic acid

oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing

Sponsors & Collaborators

  • Hospital Infantil Cândido Fontoura

    lead OTHER

Principal Investigators

  • Rodrigo S Machado, PhD · UNIFESP/EPM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Completion
2008-04-30

Countries

  • Brazil

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 NCT00521703 on ClinicalTrials.gov