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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521703
• Other study ID #: HICF 001-07
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2007
• Last updated: May 22, 2008
• Start date: August 2007
• Est. completion date: April 2008

Study information

• Verified date: May 2008
• Source: Hospital Infantil Cândido Fontoura
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Dyspepsia
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Malabsorption Syndrome
• Malabsorption Syndromes

Intervention

Drug:
• Lidocaine
oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing
• Tannic acid
oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing

Locations

Country	Name	City	State
Brazil	Hospital Infantil Cândido Fontoura	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Infantil Cândido Fontoura

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	propofol dose required to achieve adequate sedation to upper digestive endoscopy		one hour	No
Secondary	incidence of tachycardia (heart rate > 120) during the procedure		one hour	Yes
Secondary	incidence of hypoxemia (SpO2 < 94%) during procedure		one hour	Yes
Secondary	severity of sore throat after the procedure		up to 2 hours	Yes