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Completed

NCT Number: NCT03420612

Factors Associated With Pain During Unsedated Colonoscopy

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.

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Key information

Conditions

Colonoscopy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Unsedated

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, 710032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. risk factor associated with painful colonoscopy rate

    Time frame: 2 hours

    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"

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2018
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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