Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children
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|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|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|