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Factors Associated With Pain During Unsedated Colonoscopy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03420612
Enrollment
607
Registered
2018-02-05
Start date
2017-02-02
Completion date
2017-06-30
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Pain, Unsedated

Brief 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.

Interventions

None listed

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
risk factor associated with painful colonoscopy rate2 hoursAbdominal 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026