Factors Associated With Pain During Unsedated Colonoscopy

Pain Clinical Trial

Official title:

A Novel Intubation Discomfort Score Identifies Patients Feeling Painful During Unsedated Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420612
• Other study ID #: KY20163066-1
• Status: Completed
• Phase: N/A
• First received: January 29, 2018
• Last updated: January 29, 2018
• Start date: February 2, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: January 2018
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Colonoscopy
• Pain
• Unsedated

Locations

Country	Name	City	State
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

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