Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children
|ClinicalTrials.gov Identifier: NCT00521703|
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : May 23, 2008
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia Malabsorption Syndrome Gastroesophageal Reflux Disease Abdominal Pain||Drug: Lidocaine Drug: Tannic acid||Phase 3|
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%
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers|
|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
- propofol dose required to achieve adequate sedation to upper digestive endoscopy [ Time Frame: one hour ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521703
|Hospital Infantil Cândido Fontoura|
|São Paulo, Brazil, 04042-004|
|Principal Investigator:||Rodrigo S Machado, PhD||UNIFESP/EPM|