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OpenTrials
Completed

NCT Number: NCT01865721

Optimizing the Use of Entonox® During Screening Colonoscopy

This study will randomise patients undergoing screening colonoscopy to receive Entonox either continuously or as required.

Both these methods are used in the published studies of Entonox and in clinical practice.

Null hypothesis There will be no difference in pain levels between these two methods of Entonox administration

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Key information

Conditions

Bowel Cancer Screening Agnosia Analgesia Colonoscopy Entonox Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Having a bowel cancer screening programme colonoscopy

Exclusion criteria

  • Contraindications to Entonox
  • Previous bowel resections

Treatment and study plan

Entonox

Drug

Entonox will be used according to the allocated method

Primary outcomes

  1. Pain scores

    Time frame: Day 1: Prior to discharge from endoscopy department

    Patients will be asked about their overall recollection of pain on a 10 point numerical ratings scale prior to discharge

Secondary outcomes

  1. Pain scores

    Time frame: Day 1-4: Prior to discharge and 1-3 days later

    Patients will be asked about their experience of pain during colonoscopy. In addition patients will be asked about their overall recollection of pain immediately after colonoscopy and 1-3 days following colonoscopy.

  2. Use of analgesia and sedation

    Time frame: Day 1: During colonoscopy

    Patients additional use of sedation and analgesia will be compared in each treatment arm

  3. Patients satisfaction

    Time frame: Day 1-4: Prior to discharge and 1-3 days later

    Patients will be asked about their overall level of satisfaction immediately prior to discharge and 1-3 days later

  4. Willingness to have a repeat colonoscopy

    Time frame: Day 1: Prior to discharge

    Patients will be asked about their willingness to have a repeat colonoscopy prior to discharge and 1-3 days following colonoscopy

  5. Side Effects

    Time frame: Day 1: During colonoscopy

    Patients will be asked about the presence of side effects during colonoscopy. This will be quantified according to whether it limited the use Of Entonox.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study title

Optimizing the Use of Entonox® During Screening Colonoscopy: an Open Randomised Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 31, 2013
Registry last updated
Sep 23, 2019

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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