Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00521703
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : May 23, 2008
Sponsor:
Information provided by:
Hospital Infantil Cândido Fontoura

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Dyspepsia Malabsorption Syndrome Gastroesophageal Reflux Disease Abdominal Pain Drug: Lidocaine Drug: Tannic acid Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers
Study Start Date : August 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. propofol dose required to achieve adequate sedation to upper digestive endoscopy [ Time Frame: one hour ]

Secondary Outcome Measures :
  1. incidence of tachycardia (heart rate > 120) during the procedure [ Time Frame: one hour ]
  2. incidence of hypoxemia (SpO2 < 94%) during procedure [ Time Frame: one hour ]
  3. severity of sore throat after the procedure [ Time Frame: up to 2 hours ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521703


Locations
Layout table for location information
Brazil
Hospital Infantil Cândido Fontoura
São Paulo, Brazil, 04042-004
Sponsors and Collaborators
Hospital Infantil Cândido Fontoura
Investigators
Layout table for investigator information
Principal Investigator: Rodrigo S Machado, PhD UNIFESP/EPM
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00521703    
Other Study ID Numbers: HICF 001-07
First Posted: August 28, 2007    Key Record Dates
Last Update Posted: May 23, 2008
Last Verified: May 2008
Keywords provided by Hospital Infantil Cândido Fontoura:
endoscopy, gastrointestinal
lidocaine
propofol
child
adolescent
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Malabsorption Syndromes
Dyspepsia
Abdominal Pain
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Pain
Neurologic Manifestations
Intestinal Diseases
 Metabolic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action