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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00521703
Enrollment
78
Registered
2007-08-28
Start date
2007-08-31
Completion date
2008-04-30
Last updated
2008-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Dyspepsia, Gastroesophageal Reflux Disease, Malabsorption Syndrome

Keywords

endoscopy, gastrointestinal, lidocaine, propofol, child, adolescent

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%

Interventions

DRUGLidocaine

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

DRUGTannic acid

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

Sponsors

Hospital Infantil Cândido Fontoura
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
propofol dose required to achieve adequate sedation to upper digestive endoscopyone hour

Secondary

MeasureTime frame
incidence of tachycardia (heart rate > 120) during the procedureone hour
incidence of hypoxemia (SpO2 < 94%) during procedureone hour
severity of sore throat after the procedureup to 2 hours

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026