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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 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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

Secondary Outcome Measures:
  • 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 ]

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   (Child, Adult)
Sexes Eligible for Study:   All
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 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 Identifier: NCT00521703     History of Changes
Other Study ID Numbers: HICF 001-07
Study First Received: August 24, 2007
Last Updated: May 22, 2008

Keywords provided by Hospital Infantil Cândido Fontoura:
endoscopy, gastrointestinal

Additional relevant MeSH terms:
Gastroesophageal Reflux
Abdominal Pain
Malabsorption Syndromes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Intestinal Diseases
Metabolic Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers processed this record on April 28, 2017