Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children
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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 |
- propofol dose required to achieve adequate sedation to upper digestive endoscopy [ Time Frame: one hour ] [ Designated as safety issue: No ]
- 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 |
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 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 |
ClinicalTrials.gov processed this record on May 19, 2013