Carbon Dioxide Insufflation Versus Conventional Air Insufflation
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      The safety and effectiveness of esophagogastroduodenoscopy and colonoscopy in the detection
      of gastrointestinal-tract pathology in children has been established during the last three
      decades. Insufflation of the intestinal tract, usually with room air, is necessary to improve
      visualization during the procedure; however, air in the bowels can also result in abdominal
      distension and increased pain. This potential discomfort associated with upper endoscopy and
      colonoscopy may be an important barrier to patients undergoing this procedure. Insufflation
      with carbon dioxide is another method used in endoscopic procedures for distention of the
      lumen and is currently used at the Children's Hospital of Wisconsin based on provider
      preference. The aim of this study is to perform a randomized controlled trial comparing
      insufflation with room air to carbon dioxide in patients undergoing routine upper endoscopy
      and colonoscopy. The investigators primary outcome is measurement of patient comfort level as
      measured by pain scores during recovery. The investigators hypothesize that carbon dioxide
      insufflation during endoscopy and colonoscopy improves patient comfort level as compared with
      insufflation with room air. Secondary outcome measures include changes in end tidal carbon
      dioxide, time to discharge, duration of colonoscopy and cecal intubation rate, changes in
      abdominal girth, rescue pain medications used during recovery and post-procedure events. This
      is a prospective randomized single-blinded study. The investigators will recruit consecutive
      patients, between the ages of 8 and 21 years, scheduled for elective outpatient upper
      endoscopy and colonoscopy at children's hospital of Wisconsin from March 2015 until we reach
      target population numbers. The investigators will exclude all inpatients, non-English
      speaking patients, children under 8 years of age, patients undergoing colonic manometry
      studies, and patients with hemodynamic instability, gastrointestinal bleeding, acute abdomen,
      previous colectomy, oxygen-dependent pulmonary disease and obstructive sleep apnea requiring
      the use of continuous positive airway pressure device. On the basis of a computer-generated
      randomization scheme in a 1:1 ratio, patients will be assigned to receive room air or carbon
      dioxide for insufflation during colonoscopy. Power calculation was done and determined that
      we will need to enroll 100 patients in each arm of the study. Informed consent will be
      obtained from all patients by the endoscopist or gastrointestinal fellow.
    


Intervention name(s): Air; Carbon dioxide
Intervention type(s): Other; Other
Intervention description(s): Group of patients who would receive air insufflation; Group of patients who would receive carbon dioxide insufflation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Carbon dioxide; Air; Colonoscopy