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

NCT00521703 | Completed Phase 3

• 1 other identifier: HICF 001-07
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia; Malabsorption Syndrome; Gastroesophageal Reflux Disease; Abdominal Pain

Keywords

endoscopy, gastrointestinal; lidocaine; propofol; child; adolescent

Outcome Measures

Primary Outcomes (1)

• propofol dose required to achieve adequate sedation to upper digestive endoscopy

  one hour

Secondary Outcomes (3)

• 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

Study Arms (2)

1

EXPERIMENTAL

group treated

Drug: Lidocaine

2

PLACEBO COMPARATOR

control group

Drug: Tannic acid

Interventions

Lidocaine DRUG

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

1

Tannic acid DRUG

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

2

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents submitting to upper digestive endoscopy with weight above 30 kg and age between 8 and 18 years

You may not qualify if:

• Neurological disorders
• Psychiatric disorders
• Specific contra-indication to lidocaine
• Specific contra-indication to propofol

Sponsors & Collaborators

• Hospital Infantil Cândido Fontoura: lead

Study Sites (1)

Hospital Infantil Cândido Fontoura

São Paulo, São Paulo, 04042-004, Brazil

Location

MeSH Terms

Conditions

Dyspepsia; Malabsorption Syndromes; Gastroesophageal Reflux; Abdominal Pain

Interventions

Lidocaine; tannic acid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Rodrigo S Machado, PhD

  UNIFESP/EPM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 28, 2007
• Study Start: August 1, 2007
• Study Completion: April 1, 2008
• Last Updated: May 23, 2008

Record last verified: 2008-05

Locations

BR (1)