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Optimizing the Use of Entonox® During Screening Colonoscopy

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ClinicalTrials.gov Identifier: NCT01865721
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Bowel Cancer Screening Analgesia Entonox Colonoscopy Drug: Entonox Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing the Use of Entonox® During Screening Colonoscopy: an Open Randomised Controlled Trial
Study Start Date : January 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: Continuous administration of Entonox
Patients randomized to this arm will be asked to inhale Entonox throughout the insertion phase of colonoscopy
Drug: Entonox
Entonox will be used according to the allocated method

Active Comparator: As required administration of Entonox
Patients randomised to this arm will be asked to use Entonox if and when they have pain
Drug: Entonox
Entonox will be used according to the allocated method




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having a bowel cancer screening programme colonoscopy

Exclusion Criteria:

  • Contraindications to Entonox
  • Previous bowel resections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865721


Locations
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United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Stuart A Riley, MB ChB Sheffield Teaching Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01865721     History of Changes
Other Study ID Numbers: STH16359
2012-003342-33 ( EudraCT Number )
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Bowel cancer screening
Analgesia
Entonox
Pain
Side effects
Colonoscopy
Additional relevant MeSH terms:
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Nitrous Oxide
Entonox
Anesthetics, Combined
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents