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

This study has been completed.
Information provided by:
Hospital Infantil Cândido Fontoura
ClinicalTrials.gov Identifier:
First received: August 24, 2007
Last updated: May 22, 2008
Last verified: May 2008
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
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:

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%


Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

Hospital Infantil Cândido Fontoura
São Paulo, Brazil, 04042-004
Sponsors and Collaborators
Hospital Infantil Cândido Fontoura
Principal Investigator: Rodrigo S Machado, PhD UNIFESP/EPM
  More Information

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

Additional relevant MeSH terms:
Abdominal Pain
Gastroesophageal Reflux
Malabsorption Syndromes
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Intestinal Diseases
Metabolic Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Anesthetics, Local
Anti-Arrhythmia Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on May 26, 2016