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NCT Number: NCT00521703

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

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.

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Key information

Conditions

Dyspepsia Abdominal Pain Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastroesophageal Reflux Disease Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndrome Malabsorption Syndromes Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Infantil Cândido Fontoura

São Paulo, 04042-004, Brazil

About this study

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%

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing

Tannic acid

Drug

oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing

Primary outcomes

  1. propofol dose required to achieve adequate sedation to upper digestive endoscopy

    Time frame: one hour

Secondary outcomes

  1. incidence of tachycardia (heart rate > 120) during the procedure

    Time frame: one hour

  2. incidence of hypoxemia (SpO2 < 94%) during procedure

    Time frame: one hour

  3. severity of sore throat after the procedure

    Time frame: up to 2 hours

Sponsors and collaborators

Lead sponsor

Hospital Infantil Cândido Fontoura

Other

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2008
First posted
Aug 28, 2007
Registry last updated
May 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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