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

Condition(s) targeted: Dyspepsia; Malabsorption Syndrome; Gastroesophageal Reflux Disease; Abdominal Pain

Intervention: Lidocaine (Drug); Tannic acid (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hospital Infantil Cândido Fontoura

Official(s) and/or principal investigator(s):
Rodrigo S Machado, PhD, Principal Investigator, Affiliation: UNIFESP/EPM

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: propofol dose required to achieve adequate sedation to upper digestive endoscopy

Secondary outcome:

incidence of tachycardia (heart rate > 120) during the procedure

incidence of hypoxemia (SpO2 < 94%) during procedure

severity of sore throat after the procedure

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%

Minimum age: 8 Years. Maximum age: 18 Years. Gender(s): Both.

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

Hospital Infantil Cândido Fontoura, São Paulo 04042-004, Brazil

Starting date: August 2007
Ending date: April 2008
Last updated: May 22, 2008