DyspepsiaPhase 3NCT00521703
Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children
A Phase 3 study testing Lidocaine and Tannic acid in people with Dyspepsia and Malabsorption Syndrome, run by Hospital Infantil Cândido Fontoura at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Dyspepsia, Malabsorption Syndrome, Gastroesophageal Reflux Disease
- What is being tested?
- Lidocaine and Tannic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2007to Apr 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents submitting to upper digestive endoscopy with weight above 30 kg and age between 8 and 18 years
Who cannot join
- Neurological disorders
- Psychiatric disorders
- Specific contra-indication to lidocaine
- Specific contra-indication to propofol
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Infantil Cândido Fontoura
São Paulo, São Paulo, 04042-004
About this study
Official title: 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.
Read the 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%
- Being tested
- Lidocaine, Tannic acid
- Keywords
- endoscopy, gastrointestinal, lidocaine, propofol, child, adolescent
- Medical subject headings
- Dyspepsia, Malabsorption Syndromes, Gastroesophageal Reflux, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing
Tannic acidDrug
oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | group treated Receives: Drug: Lidocaine |
| 2 | Placebo comparator | control group Receives: Drug: Tannic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
propofol dose required to achieve adequate sedation to upper digestive endoscopy
Measured: one hour
Secondary outcomes (3)
incidence of tachycardia (heart rate > 120) during the procedure
Measured: one hour
incidence of hypoxemia (SpO2 < 94%) during procedure
Measured: one hour
severity of sore throat after the procedure
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startAug 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil Cândido Fontoura
- Sponsor type
- University, hospital or other
- Investigators
- Rodrigo S Machado, PhD, Principal investigator, UNIFESP/EPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521703
- Sponsor's protocol ID
- HICF 001-07
- Status last verified
- May 2008
- First submitted
- 24 Aug 2007
- Last updated
- 23 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers
- ClinicalTrials.gov ID
- NCT00521703
- Acronym / sponsor ID
- HICF 001-07
- Keywords
- endoscopy, gastrointestinal, lidocaine, propofol, child, adolescent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hospital Infantil Cândido FontouraUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Apr 2008 (actual)
- First posted
- 28 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lidocainegroup treated |
| 2 | Placebo comparator | Drug: Tannic acidcontrol group |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children and adolescents submitting to upper digestive endoscopy with weight above 30 kg and age between 8 and 18 years
Key exclusion criteria (4 listed)
- Neurological disorders
- Psychiatric disorders
- Specific contra-indication to lidocaine
- Specific contra-indication to propofol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaineoral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing | Drug | 1 |
| Tannic acidoral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing | Drug | 2 |
Primary outcome
propofol dose required to achieve adequate sedation to upper digestive endoscopy
Time frame: one hour
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo S Machado, PhD principal investigator
UNIFESP/EPM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine and Tannic acid in people with Dyspepsia and Malabsorption Syndrome, run by Hospital Infantil Cândido Fontoura at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
propofol dose required to achieve adequate sedation to upper digestive endoscopy (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2008.