Abdominal PainNCT06134154
Safety and Efficacy of Carbon Dioxide Gas for Endoscopy
A study testing Endoscopic insufflation gas in people with Abdominal Pain, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Endoscopic insufflation gas
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to Dec 2028
- Phase
- Interventional
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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Infants and children 6 months to 18 years undergoing any upper endoscopy related procedure including but not limited to EGD/Colonoscopy, ERCP, EGD only, EUS, EGD with foreign body removal, Enteroscopy.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Chinenye R Dike, MD, 3345585519, cdike@uabmc.edu
About this study
Official title: Safety and Efficacy of Carbon Dioxide Gas for Endoscopic Insufflation in Children
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.
Read the detailed description
In this study, children (6 months -18 years) undergoing all endoscopic procedures that includes an upper endoscopy including but not limited to Esophagogastroduodenoscopy (EGD/ upper endoscopy), EGD/ Colonoscopy, Endoscopic Retrograde Cholangiopancreatography (ERCP), Endoscopic ultrasound (EUS) e.t.c after appropriate consent, will be randomized 1:1 to either Air or CO2 gas for endoscopic insufflation. We will record demographics (name, age, sex, MRN, race/ethnicity), anthropometrics including weight, height/length, weight for length (WFL), WFL z score, BMI, BMI z score, indication/ reason for scope, other co-morbidities (other medical problems), personnel involved (faculty only, vs faculty + trainee), minute by minute end tidal CO2 levels, minute by minute minute ventilation levels, baseline blood pCO2, and blood pCO2 after each procedure. Pre and post procedure patient reported abdominal pain, bloating and flatulence. Pre and post procedure nurse assessed pain. Pre and post procedure vital signs. Patients will be randomized using a sealed envelope method by the endoscopy technician. Both patients and providers will be blinded to arm of enrollment.
- Conditions
- Abdominal Pain
- Being tested
- Endoscopic insufflation gas
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic insufflation gasOther
Carbon dioxide gas versus air for endoscopic insufflation
| Study group | Role | What they receive |
|---|---|---|
| Air | Placebo comparator | Not described Receives: Other: Endoscopic insufflation gas |
| Carbondioxide | Experimental | Not described Receives: Other: Endoscopic insufflation gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Pain
Rates of abdominal pain from pre-procedure to immediately after the procedure
Measured: baseline/ pre-procedure to immediately after the procedure
Secondary outcomes (1)
PCO2 level
Incidence of elevated carbon dioxide level in the blood from pre-procedure to post -procedure
Measured: baseline/ preprocedural to immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start24 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chinenye Dike, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134154
- Sponsor's protocol ID
- IRB-300011252
- Status last verified
- Jan 2026
- First submitted
- 24 Oct 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No