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
  Purpose

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.


Condition Intervention Phase
Dyspepsia
Malabsorption Syndrome
Gastroesophageal Reflux Disease
Abdominal Pain
Drug: Lidocaine
Drug: Tannic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers

Resource links provided by NLM:


Further study details as provided by Hospital Infantil Cândido Fontoura:

Primary Outcome Measures:
  • propofol dose required to achieve adequate sedation to upper digestive endoscopy [ Time Frame: one hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 78
Study Start Date: August 2007
Study Completion Date: April 2008
Arms Assigned Interventions
Experimental: 1
group treated
Drug: Lidocaine
oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing
Placebo Comparator: 2
control group
Drug: Tannic acid
oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing

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%

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521703

Locations
Brazil
Hospital Infantil Cândido Fontoura
São Paulo, Brazil, 04042-004
Sponsors and Collaborators
Hospital Infantil Cândido Fontoura
Investigators
Principal Investigator: Rodrigo S Machado, PhD UNIFESP/EPM
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00521703     History of Changes
Other Study ID Numbers: HICF 001-07
Study First Received: August 24, 2007
Last Updated: May 22, 2008
Health Authority: Brazil: Ministry of Health

Keywords provided by Hospital Infantil Cândido Fontoura:
endoscopy, gastrointestinal
lidocaine
propofol
child
adolescent

Additional relevant MeSH terms:
Abdominal Pain
Dyspepsia
Gastroesophageal Reflux
Malabsorption Syndromes
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Metabolic Diseases
Benzocaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on August 27, 2014