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

Phase 3

Completed

• Conditions: Dyspepsia; Malabsorption Syndrome; Gastroesophageal Reflux Disease; Abdominal Pain
• Interventions: Drug: Lidocaine; Drug: Tannic acid

• Registration Number: NCT00521703
• Lead Sponsor: Hospital Infantil Cândido Fontoura

Brief Summary

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

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-24
• Study First Submitted QC: 2007-08-27
• Study First Posted: 2007-08-28
• Study Completion: 2008-04
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-22
• Last Update Posted: 2008-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lidocaine	group treated
2	Tannic acid	control group

Primary Outcome Measures

Name	Time	Method
propofol dose required to achieve adequate sedation to upper digestive endoscopy	one hour

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Infantil Cândido Fontoura; 🇧🇷 São Paulo, Brazil