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

Primary Purpose

Dyspepsia, Malabsorption Syndrome, Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Lidocaine
Tannic acid
Sponsored by
Hospital Infantil Cândido Fontoura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring endoscopy, gastrointestinal, lidocaine, propofol, child, adolescent

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Infantil Cândido Fontoura

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

group treated

control group

Outcomes

Primary Outcome Measures

propofol dose required to achieve adequate sedation to upper digestive endoscopy

Secondary Outcome Measures

incidence of tachycardia (heart rate > 120) during the procedure
incidence of hypoxemia (SpO2 < 94%) during procedure
severity of sore throat after the procedure

Full Information

First Posted
August 24, 2007
Last Updated
May 22, 2008
Sponsor
Hospital Infantil Cândido Fontoura
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1. Study Identification

Unique Protocol Identification Number
NCT00521703
Brief Title
Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children
Official Title
Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Infantil Cândido Fontoura

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Malabsorption Syndrome, Gastroesophageal Reflux Disease, Abdominal Pain
Keywords
endoscopy, gastrointestinal, lidocaine, propofol, child, adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
group treated
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
control group
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing
Intervention Type
Drug
Intervention Name(s)
Tannic acid
Intervention Description
oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing
Primary Outcome Measure Information:
Title
propofol dose required to achieve adequate sedation to upper digestive endoscopy
Time Frame
one hour
Secondary Outcome Measure Information:
Title
incidence of tachycardia (heart rate > 120) during the procedure
Time Frame
one hour
Title
incidence of hypoxemia (SpO2 < 94%) during procedure
Time Frame
one hour
Title
severity of sore throat after the procedure
Time Frame
up to 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo S Machado, PhD
Organizational Affiliation
UNIFESP/EPM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Infantil Cândido Fontoura
City
São Paulo
ZIP/Postal Code
04042-004
Country
Brazil

12. IPD Sharing Statement

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

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