Gastroesophageal Reflux Disease Clinical Trial
Official title:
Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers
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.
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%
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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