Pain Clinical Trial
Official title:
A Novel Intubation Discomfort Score Identifies Patients Feeling Painful During Unsedated Colonoscopy
Verified date | January 2018 |
Source | Fourth Military Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Colonoscopy is the gold standard in the diagnosis and treatment colorectal disease, but due to the uncomfortable or even painful procedure, a part of people unwilling to undergoing the examination and giving analgesic agents were recommended in several guidelines. However, use of analgesic agents have their own drawbacks, and nearly 70% patients felt no pain or only mild discomfort with the unsedated colonoscopy, routine administration of sedative or analgesic agents to all patients was considered as unnecessary. However, unsedated colonoscopy was thought to be an option for some but not for all, therefore a method to identify which patients at high risk for painful colonoscopy in preoperational stage is necessary.
Status | Completed |
Enrollment | 607 |
Est. completion date | June 30, 2017 |
Est. primary completion date | May 12, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - aged 18-80 years - underwent unsedated colonoscopy Exclusion Criteria: - no bowel preparation or colon cleansing by enema only - no need to reach cecum - prior finding of severe colon stenosis or obstructing tumor - history of colectomy - unstable hemodynamics - pregnant - unable to give informed consent. |
Country | Name | City | State |
---|---|---|---|
China | Endoscopic center, Xijing Hospital of Digestive Diseases | Xi'an |
Lead Sponsor | Collaborator |
---|---|
Fourth Military Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | risk factor associated with painful colonoscopy rate | Abdominal pain during the examination was evaluated by a previously validated 4-point verbal rating scale (no, slight, moderate, severe pain)[14], and moderate or severe pain during the procedure was defined as a "painful colonoscopy" | 2 hours |
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