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

May 22, 2008 updated by: Hospital Infantil Cândido Fontoura

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized double-blind placebo-controlled clinical trial.

Primary outcome: propofol doses required to achieve adequate sedation.

Population: children submitting to upper digestive endoscopy, weight > 30 kg and age between 8 and 18 years.

Exclusion criteria: neurological disorders, psychiatric disorders, specific contra-indication to either lidocaine or propofol.

Estimated sample: 160 patients. Placebo: tannic acid 0.5%

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04042-004
        • Hospital Infantil Cândido Fontoura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children and adolescents submitting to upper digestive endoscopy with weight above 30 kg and age between 8 and 18 years

Exclusion Criteria:

  • Neurological disorders
  • Psychiatric disorders
  • Specific contra-indication to lidocaine
  • Specific contra-indication to propofol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
group treated
Drug: Lidocaine
oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing
Placebo Comparator: 2
control group
Drug: Tannic acid
oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
propofol dose required to achieve adequate sedation to upper digestive endoscopy
Time Frame: one hour
one hour

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of tachycardia (heart rate > 120) during the procedure
Time Frame: one hour
one hour
incidence of hypoxemia (SpO2 < 94%) during procedure
Time Frame: one hour
one hour
severity of sore throat after the procedure
Time Frame: up to 2 hours
up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Infantil Cândido Fontoura

Investigators

  • Principal Investigator: Rodrigo S Machado, PhD, Unifesp/Epm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

August 24, 2007

First Submitted That Met QC Criteria

August 27, 2007

First Posted (Estimate)

August 28, 2007

Study Record Updates

Last Update Posted (Estimate)

May 23, 2008

Last Update Submitted That Met QC Criteria

May 22, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HICF 001-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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