Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00521703 |
|
Recruitment Status :
Completed
First Posted : August 28, 2007
Last Update Posted : May 23, 2008
|
Sponsor:
Hospital Infantil Cândido Fontoura
Information provided by:
Hospital Infantil Cândido Fontoura
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dyspepsia Malabsorption Syndrome Gastroesophageal Reflux Disease Abdominal Pain | Drug: Lidocaine Drug: Tannic acid | Phase 3 |
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%
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 78 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers |
| Study Start Date : | August 2007 |
| Actual Study Completion Date : | April 2008 |
| Arm | Intervention/treatment |
|---|---|
|
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 |
Primary Outcome Measures :
- propofol dose required to achieve adequate sedation to upper digestive endoscopy [ Time Frame: one hour ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 8 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| ClinicalTrials.gov Identifier: | NCT00521703 History of Changes |
| Other Study ID Numbers: |
HICF 001-07 |
| First Posted: | August 28, 2007 Key Record Dates |
| Last Update Posted: | May 23, 2008 |
| Last Verified: | May 2008 |
Keywords provided by Hospital Infantil Cândido Fontoura:
|
endoscopy, gastrointestinal lidocaine propofol child adolescent |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Dyspepsia Abdominal Pain Malabsorption Syndromes Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Signs and Symptoms, Digestive Signs and Symptoms Pain Neurologic Manifestations Nervous System Diseases Intestinal Diseases |
Metabolic Diseases Lidocaine Benzocaine Propofol Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |