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

Tracking Information

First Received Date ^ICMJE

August 24, 2007

Last Updated Date

May 22, 2008

Start Date ^ICMJE

August 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

propofol dose required to achieve adequate sedation to upper digestive endoscopy [ Time Frame: one hour ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

propofol dose required to achieve adequate sedation to upper digestive endoscopy [ Time Frame: one hour ]

Change History

Complete list of historical versions of study NCT00521703 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

incidence of tachycardia (heart rate > 120) during the procedure [ Time Frame: one hour ] [ Designated as safety issue: Yes ]
incidence of hypoxemia (SpO2 < 94%) during procedure [ Time Frame: one hour ] [ Designated as safety issue: Yes ]
severity of sore throat after the procedure [ Time Frame: up to 2 hours ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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%

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Dyspepsia
Malabsorption Syndrome
Gastroesophageal Reflux Disease
Abdominal Pain

Intervention ^ICMJE

Drug: Lidocaine
Drug: Tannic acid

Study Arms / Comparison Groups

Experimental: group treated
Placebo Comparator: control group

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT ID ^ICMJE

NCT00521703

Responsible Party

Study ID Numbers ^ICMJE

HICF 001-07

Study Sponsor ^ICMJE

Hospital Infantil Cândido Fontoura

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Rodrigo S Machado, PhD

UNIFESP/EPM

Information Provided By

Hospital Infantil Cândido Fontoura

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP