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

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Malabsorption Syndromes

Drug Information available for: Lidocaine hydrochloride Lidocaine Tannic acid

U.S. FDA Resources

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
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

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

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, see Learn About Clinical Studies.

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


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

Keywords provided by Hospital Infantil Cândido Fontoura:


endoscopy, gastrointestinal lidocaine propofol child adolescent

Additional relevant MeSH terms:


Gastroesophageal Reflux Malabsorption Syndromes Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Intestinal Diseases Metabolic Diseases Lidocaine Anesthetics Anesthetics, Local Anti-Arrhythmia Agents	Cardiovascular Agents Central Nervous System Agents Central Nervous System Depressants Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Sodium Channel Blockers Therapeutic Uses Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on March 03, 2015