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

This study has been completed.
Sponsor:
Information provided by:
Hospital Infantil Cândido Fontoura
ClinicalTrials.gov Identifier:
NCT00521703
First received: August 24, 2007
Last updated: May 22, 2008
Last verified: May 2008

August 24, 2007
May 22, 2008
August 2007
Not Provided
propofol dose required to achieve adequate sedation to upper digestive endoscopy [ Time Frame: one hour ] [ Designated as safety issue: No ]
propofol dose required to achieve adequate sedation to upper digestive endoscopy [ Time Frame: one hour ]
Complete list of historical versions of study NCT00521703 on ClinicalTrials.gov Archive Site
  • incidence of tachycardia (heart rate > 120) during the procedure [ Time Frame: one hour ] [ Designated as safety issue: Yes ]
  • incidence of hypoxemia (SpO2 < 94%) during procedure [ Time Frame: one hour ] [ Designated as safety issue: Yes ]
  • severity of sore throat after the procedure [ Time Frame: up to 2 hours ] [ Designated as safety issue: Yes ]
  • incidence of tachycardia (heart rate > 120) during the procedure [ Time Frame: one hour ]
  • incidence of hypoxemia (SpO2 < 94%) during procedure [ Time Frame: one hour ]
  • severity of sore throat after the procedure [ Time Frame: up to 2 hours ]
Not Provided
Not Provided
 
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

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.

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%

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Dyspepsia
  • Malabsorption Syndrome
  • Gastroesophageal Reflux Disease
  • Abdominal Pain
  • Drug: Lidocaine
    oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing
  • Drug: Tannic acid
    oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing
  • Experimental: 1
    group treated
    Intervention: Drug: Lidocaine
  • Placebo Comparator: 2
    control group
    Intervention: Drug: Tannic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
April 2008
Not Provided

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
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00521703
HICF 001-07
No
Not Provided
Hospital Infantil Cândido Fontoura
Not Provided
Principal Investigator: Rodrigo S Machado, PhD UNIFESP/EPM
Hospital Infantil Cândido Fontoura
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP