Safety and Efficacy of Carbon Dioxide Gas for Endoscopy
ConditionAbdominal Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorUniversity of Alabama at Birmingham
About this trial
The goal of this clinical trial is to compare the efficacy and safety of air versus carbon dioxide gas insufflation for endoscopy in children.
The main question\[s\] it aims to answer are:
•to determine safety of CO2 Assess patient comfort (abdominal pain, flatulence and bloating) with CO2 use when compared to air.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients with American Society of Anesthesiology (ASA) Physical Status Classification System of 4 and above
Children with chronic lung disease,
Children who are wards of the state will be excluded.
Children needing language interpreting services that is not Spanish.
Trial design
Design model
Parallel
Treatments tested in this trial
Endoscopic insufflation gas
Other interventionCarbon dioxide gas versus air for endoscopic insufflation
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: AirPlacebo comparator 1 intervention
Group B: CarbondioxideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Abdominal Pain
Rates of abdominal pain from pre-procedure to immediately after the procedure
Time frame
baseline/ pre-procedure to immediately after the procedureSecondary outcomes
1
PCO2 level
Incidence of elevated carbon dioxide level in the blood from pre-procedure to post -procedure
Time frame
baseline/ preprocedural to immediately after the procedureSponsors and contacts
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Source ClinicalTrials.gov