Carbon Dioxide Gas for Endoscopy in Children

Overseen By Chinenye R Dike, MD MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Chronic lung disease, ASA 4+, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if carbon dioxide gas is safer and more comfortable than air during endoscopy for children. It specifically compares the effects of each gas on abdominal pain, bloating, and discomfort. Children aged 6 months to 18 years scheduled for upper endoscopy procedures, such as EGD or colonoscopy, may qualify for this study. The trial includes two groups: one using air and the other using carbon dioxide gas. As an unphased trial, it provides a unique opportunity for participants to contribute to research that could enhance comfort and safety in pediatric endoscopy.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that carbon dioxide gas is safe for endoscopy in children?

Research has shown that using carbon dioxide (CO2) gas for endoscopy in children is generally safe. One study found that CO2 is as safe as air for this procedure and causes less abdominal discomfort and bloating. Another study suggested that CO2 might reduce post-procedure pain compared to air.

CO2 has also been used safely in similar procedures for adults, which increases confidence in its use for children. In a trial with 200 children, CO2 reduced pain and discomfort after the procedure. Overall, these findings suggest that CO2 is well-tolerated and safe for use in children's endoscopies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using carbon dioxide (CO2) gas for endoscopy in children because it can potentially make the procedure more comfortable. Unlike the common practice of using air, CO2 is absorbed by the body much faster, which might reduce bloating and discomfort after the procedure. This quick absorption could lead to a smoother recovery and less post-procedure pain, making the overall experience better for young patients.

What evidence suggests that carbon dioxide gas is effective for endoscopy in children?

Research has shown that using carbon dioxide (CO2) instead of air during endoscopies in children can reduce pain and discomfort after the procedure. In this trial, participants will receive either CO2 or air during their endoscopy. Studies have found that CO2 leads to less belly pain, bloating, and gas compared to air. One study discovered that using CO2 in children's endoscopies significantly lowered the chances of pain without adding any risk. Additionally, a review of multiple studies confirmed that CO2 is more effective at reducing post-procedure pain than air. Overall, CO2 has proven to be safe and as effective as air, making it a promising option for more comfortable endoscopies in children. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for infants and children aged 6 months to 18 years who need an upper endoscopy procedure, such as EGD/Colonoscopy or ERCP. It's not for kids who are wards of the state, those needing non-Spanish language interpreting services, or with chronic lung disease or severe systemic illness (ASA level 4+).

Exclusion Criteria

My child has a long-term lung condition.

My child needs a non-Spanish language interpreter.

Children who are wards of the state will be excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children undergo endoscopic procedures with either air or CO2 gas insufflation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Immediately after the procedure

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Carbon Dioxide Gas

Trial Overview

The study is testing if using carbon dioxide gas during endoscopy is safer and more comfortable than air. Children will be randomly assigned to receive either CO2 or air to see which causes less abdominal pain, flatulence, and bloating.

How Is the Trial Designed?

Group I: Carbondioxide Experimental Treatment 1 Intervention

Group II: Air Placebo Group 1 Intervention

Carbon Dioxide Gas is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Carbon dioxide gas for:

• Endoscopy insufflation

Approved in European Union as Carbon dioxide gas for:

• Endoscopy insufflation

Approved in Canada as Carbon dioxide gas for:

• Endoscopy insufflation

Approved in Japan as Carbon dioxide gas for:

• Endoscopy insufflation

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Pediatric gastrointestinal endoscopy is generally safe and effective for diagnosing and managing various gastrointestinal diseases, but certain patient factors can increase the risk of adverse events (AEs) such as bleeding, perforation, and infection.

High-risk patients, including those with congenital heart disease or compromised immune systems, require careful risk stratification and specific clinical practices, like CO2 insufflation and proper endoscopic techniques, to minimize potential complications during and after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Endoscopy and High-risk Patients: A Clinical Report From the NASPGHAN Endoscopy Committee. Lightdale, JR., Liu, QY., Sahn, B., et al.[2021]

In a study of 97 children undergoing colonoscopy, the use of carbon dioxide (CO2) instead of room air significantly reduced the incidence of abdominal bloating (P = 0.0012) and decreased the need for additional opioids for sedation (P = 0.023).

While there was only a trend towards lower post-interventional pain with CO2 (P = 0.15), the overall findings suggest that CO2 insufflation is safe and may lead to a more comfortable recovery for deeply sedated pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon dioxide versus room air for colonoscopy in deeply sedated pediatric patients: a randomized controlled trial. Kresz, A., Mayer, B., Zernickel, M., et al.[2020]

In a study involving 178 pediatric patients undergoing endoscopic procedures, the use of carbon dioxide (CO2) for insufflation did not significantly reduce abdominal discomfort or improve ease of procedure compared to air.

While CO2 was associated with less bloating and flatulence, it also caused transient spikes in end-tidal CO2 levels, raising concerns about potential systemic hypercarbia, which questions its routine use in pediatric endoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Carbon Dioxide Insufflation During Endoscopy in Children as Safe and as Effective as We Think? Dike, CR., Rahhal, R., Bishop, WP.[2021]

In a study of 100 deeply sedated children undergoing colonoscopy, CO2 insufflation was associated with significantly lower postprocedural abdominal pain compared to air insufflation, particularly after adjusting for baseline pain factors.

CO2 insufflation also led to a decrease in abdominal circumference after the procedure, suggesting it may be a safer and more effective option for reducing discomfort during pediatric colonoscopies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Carbon Dioxide Versus Air Insufflation for Colonoscopy in Deeply Sedated Pediatric Patients. Dharmaraj, R., Dunn, R., Fritz, J., et al.[2021]

In a study involving 59 children undergoing esophagogastroduodenoscopy (EGD), those receiving carbon dioxide (CO2) insufflation showed transient elevations in end-tidal CO2 (EtCO2) levels, but these were not linked to significant increases in systemic CO2 levels as measured by transcutaneous CO2 (tCO2).

The findings suggest that the elevated EtCO2 during CO2 insufflation is likely due to eructated CO2 rather than excessive systemic absorption, indicating that CO2 insufflation is safe for use in non-intubated pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient End-Tidal Carbon Dioxide Elevation During Pediatric Upper Endoscopy With Carbon Dioxide Insufflation: Is It True Hypercapnia? Dike, CR., Bishop, WP., Titler, SS., et al.[2023]

In a study of 309 patients undergoing ileo-colonoscopy and gastroscopy, using carbon dioxide (CO2) for insufflation significantly reduced abdominal pain compared to air, indicating better patient comfort post-procedure.

Patients who received CO2 insufflation also experienced less abdominal distension, as shown by a smaller increase in waist circumference after the procedures, highlighting the efficacy of CO2 in minimizing discomfort during endoscopic examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon dioxide vs. air insufflation in ileo-colonoscopy and in gastroscopy plus ileo-colonoscopy: a comparative study. Fernández-Calderón, M., Muñoz-Navas, MÁ., Carrascosa-Gil, J., et al.[2019]

In a study of 40 pediatric patients undergoing outpatient colonoscopy, those who received CO2 insufflation reported significantly lower post-procedure pain compared to those who received air insufflation, particularly at 1 and 6 hours after the procedure.

The study found that CO2 insufflation is as safe as air, with no significant differences in end tidal CO2 levels between the two groups, suggesting that CO2 is an effective option for reducing pain in pediatric colonoscopies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insufflation With Carbon Dioxide During Pediatric Colonoscopy for Control of Postprocedure Pain. Thornhill, C., Navarro, F., Alabd Alrazzak, B., et al.[2019]

A study involving 110 COPD patients undergoing extended endoscopic procedures found that CO2 insufflation is safe, with only a slight increase in end-tidal CO2 (EtCO2) levels during and after the procedure.

The incidence of complications, such as difficulty in extubation, was low and comparable between COPD patients (2.8%) and non-COPD patients (0.9%), suggesting that CO2 insufflation does not significantly increase risks for patients with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of chronic obstructive pulmonary disease patients undergoing carbon dioxide insufflation in extended endoscopic procedures. Helgeson, SA., Lewis, KL., Carter, LE., et al.[2022]

In a pilot study involving 37 children aged 5 to 17, inhaled nitrous oxide (Entonox) was found to provide rapid and effective sedation for gastrointestinal endoscopy, with 92% of endoscopists rating the sedation efficacy as good or excellent.

The use of Entonox resulted in minimal pain scores (median of 20 for upper GI endoscopy) and allowed for quick discharge from the endoscopy suite, indicating it may be a safe and efficient alternative to traditional sedation methods, although further randomized studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nitrous oxide sedation in pediatric patients undergoing gastrointestinal endoscopy. Michaud, L., Gottrand, F., Ganga-Zandzou, PS., et al.[2019]

In a study of 195 pediatric patients undergoing esophagogastroduodenoscopy (EGD), transient elevations in exhaled carbon dioxide (EtCO2) were more common with carbon dioxide (CO2) insufflation compared to air insufflation (16% vs 5%), particularly when using a laryngeal mask airway (LMA).

Despite these transient elevations in EtCO2, there were no significant changes in minute ventilation (MV) or adverse clinical effects observed, suggesting that while CO2 may reduce post-procedural flatulence, caution is warranted due to the increased risk of elevated EtCO2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elevations in End-Tidal CO 2 With CO 2 Use During Pediatric Endoscopy With Airway Protection: Is This Physiologically Significant? Dike, CR., Huang Pacheco, A., Lyden, E., et al.[2023]

In a review of five randomized controlled trials involving 450 pediatric patients, CO2 insufflation during gastrointestinal endoscopic procedures significantly reduced postoperative pain compared to air insufflation, with an odds ratio of 0.40.

There were no significant differences in abdominal distention between the two groups, and while CO2 levels were elevated in some patients, no pulmonary complications were reported, suggesting CO2 is safe for use in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon Dioxide vs. Air Insufflation for Pediatric Gastrointestinal Endoscopy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ji, C., Liu, X., Huang, P.[2021]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32304555/

Is Carbon Dioxide Insufflation During Endoscopy in Children ...

Conclusions: The benefits of using CO2 for insufflation were minimal in our patients. The observed transient elevations of EtCO2 during sedated upper endoscopy ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7899965/

Carbon Dioxide vs. Air Insufflation for Pediatric ...

Our study indicates that the incidence of pain may be reduced with the use of CO 2 insufflation in pediatric GI endoscopies without a significant risk of ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03287687

NCT03287687 | Safety and Efficacy of CO2 for Endoscopy

Hypothesis: Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal distension and discomfort; it is equally effective as ...

4.

e-ce.org

e-ce.org/journal/view.php?doi=10.5946/ce.2020.275

Insufflation of Carbon Dioxide versus Air During ...

The results obtained from this meta-analysis and systematic review, including only RCTs showed that the use of CO2 reduces post-procedure pain; ...

5.

e-cep.org

e-cep.org/journal/view.php?number=20125555797

Efficacy and safety of carbon dioxide versus room-air ...

This randomized controlled trial of 200 children showed that CO2 insufflation reduces postprocedure pain and discomfort during pediatric ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10097482/

Elevations in End-Tidal CO2 With CO2 Use During ...

Carbon dioxide (CO2) is increasingly used over air for endoscopic insufflation in children, largely based on adult studies demonstrating its safety and, in most ...

7.

frontiersin.org

frontiersin.org/journals/pediatrics/articles/10.3389/fped.2021.610066/full

Carbon Dioxide vs. Air Insufflation for Pediatric ...

Conclusion: Our study indicates that the incidence of pain may be reduced with the use of CO2 insufflation in pediatric GI endoscopies without a ...