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

NCT ID: NCT00521703

Last Updated: 2008-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2008-04-30

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%

Conditions

Dyspepsia; Malabsorption Syndrome; Gastroesophageal Reflux Disease; Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

group treated

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing

2

control group

Group Type: PLACEBO_COMPARATOR

Tannic acid

Intervention Type: DRUG

oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing

Interventions

Lidocaine

oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing

Intervention Type: DRUG

Tannic acid

oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Infantil Cândido Fontoura

OTHER

Sponsor Role: lead

Principal Investigators

Rodrigo S Machado, PhD

Role: PRINCIPAL_INVESTIGATOR

UNIFESP/EPM

Locations

Hospital Infantil Cândido Fontoura

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

HICF 001-07

Identifier Type: -

Identifier Source: org_study_id