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.
Gastroesophageal Reflux Disease
Drug: Tannic acid
|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|
- propofol dose required to achieve adequate sedation to upper digestive endoscopy [ Time Frame: one hour ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||August 2007|
|Study Completion Date:||April 2008|
oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing
Placebo Comparator: 2
Drug: Tannic acid
oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing
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%
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521703
|Hospital Infantil Cândido Fontoura|
|São Paulo, Brazil, 04042-004|
|Principal Investigator:||Rodrigo S Machado, PhD||UNIFESP/EPM|