Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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%

Official Title
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Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers

Conditions
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Dyspepsia, Malabsorption Syndrome, Gastroesophageal Reflux Disease, Abdominal Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Tannic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adolescents submitting to upper digestive endoscopy with weight above 30 kg and age between 8 and 18 years Exclusion Criteria: Neurological disorders Psychiatric disorders Specific contra-indication to lidocaine Specific contra-indication to propofol

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>group treated | Drug: Lidocaine<br>* oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing<br>|
| Placebo Comparator: 2<br>control group | Drug: Tannic acid<br>* oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| propofol dose required to achieve adequate sedation to upper digestive endoscopy |  | one hour | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | up to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopy, gastrointestinal, lidocaine, propofol, child, adolescent