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

Sponsored by:	Hospital Infantil Cândido Fontoura
Information provided by:	Hospital Infantil Cândido Fontoura
ClinicalTrials.gov Identifier:	NCT00521703

Purpose

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	Intervention	Phase
Dyspepsia Malabsorption Syndrome Gastroesophageal Reflux Disease Abdominal Pain	Drug: Lidocaine Drug: Tannic acid	Phase III

MedlinePlus related topics: Abdominal Pain Anesthesia Endoscopy GERD Indigestion

Drug Information available for: Lidocaine Tannic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers

Further study details as provided by Hospital Infantil Cândido Fontoura:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	78
Study Start Date:	August 2007
Study Completion Date:	April 2008

Arms	Assigned Interventions
1: Experimental group treated	Drug: Lidocaine oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing
2: Placebo Comparator control group	Drug: Tannic acid oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing

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%

Eligibility

Ages Eligible for Study:	8 Years to 18 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521703

Locations

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

Sponsors and Collaborators

Hospital Infantil Cândido Fontoura

Investigators

Principal Investigator:

Rodrigo S Machado, PhD

UNIFESP/EPM

More Information

No publications provided

Study ID Numbers:	HICF 001-07
Study First Received:	August 24, 2007
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00521703 History of Changes
Health Authority:	Brazil: Ministry of Health

Keywords provided by Hospital Infantil Cândido Fontoura:

endoscopy, gastrointestinal
lidocaine
propofol
child
adolescent

Study placed in the following topic categories:

Signs and Symptoms, Digestive
Gastrointestinal Diseases
Abdominal Pain
Anesthetics
Pain
Gastroesophageal Reflux
Deglutition Disorders
Signs and Symptoms
Anti-Arrhythmia Agents
Propofol
Metabolic Disorder
Metabolic Diseases
Lidocaine

Adjuvants, Immunologic
Central Nervous System Depressants
Cardiovascular Agents
Intestinal Diseases
Dyspepsia
Anesthetics, Local
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder
Malabsorption Syndromes
Esophageal Diseases
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Signs and Symptoms, Digestive
Gastrointestinal Diseases
Abdominal Pain
Physiological Effects of Drugs
Anesthetics
Pain
Gastroesophageal Reflux
Deglutition Disorders
Signs and Symptoms
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Syndrome
Anti-Arrhythmia Agents
Metabolic Diseases

Disease
Lidocaine
Central Nervous System Depressants
Cardiovascular Agents
Dyspepsia
Intestinal Diseases
Anesthetics, Local
Pharmacologic Actions
Esophageal Motility Disorders
Digestive System Diseases
Malabsorption Syndromes
Esophageal Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009