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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%
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | group treated |
|
| 2 | Placebo Comparator | control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing |
|
| Measure | Description | Time Frame |
|---|---|---|
| propofol dose required to achieve adequate sedation to upper digestive endoscopy | one hour |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of tachycardia (heart rate > 120) during the procedure | one hour | |
| incidence of hypoxemia (SpO2 < 94%) during procedure | one hour | |
| severity of sore throat after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo S Machado, PhD | UNIFESP/EPM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Infantil Cândido Fontoura | São Paulo | São Paulo | 04042-004 | Brazil |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D008286 | Malabsorption Syndromes |
| D005764 | Gastroesophageal Reflux |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C000726650 | tannic acid |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Tannic acid | Drug | oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing |
|
| up to 2 hours |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| Aniline Compounds |
| D000588 | Amines |