drugset / Trial / NCT03287687

Safety and Efficacy of CO2 for Endoscopy

NCT03287687

Phase 4 Completed 180 enrolled Warren Bishop
RandomizedParallel-groupQuadruple-blindOther

Summary

Hypothesis: Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal distension and discomfort; it is equally effective as air in pediatric patients undergoing endoscopic procedures. Aim 1: Determine the occurrence and severity of abdominal discomfort and distension associated with endoscopic procedures at baseline, upon awakening from anesthesia, at discharge and at 4 hours after discharge in carbon dioxide group when compared to the air group. Aim 2: Determine if the expertise level of the endoscopist contributes to abdominal discomfort and distension following endoscopy, and whether this differs in the carbon dioxide group versus air group. Aim 3: Determine if carbon dioxide is as effective as air for insufflation.

Timeline

Start
2017-11-27
Primary completion
2019-04-09
Completion
2019-04-09

Drugs

EvaluationDrugModalityDoseRoute
Subject carbon dioxide Other / unclassified

Indications

No indication recorded.