Optimising the use of Entonox during screening colonoscopy

Optimising the use of Entonox during screening colonoscopy: an open randomised controlled trial - Optimising the use of Entonox during screening colonoscopy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003342-33-GB

Enrollment

198

Registered

2012-09-24

Start date

2012-09-28

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Colonoscopy MedDRA version: 14.1 Level: PT Classification code 10010007 Term: Colonoscopy System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Entonox Product Name: Entonox Pharmaceutical Form: Pressurised inhalation INN or Proposed INN: Nitrous oxide and Oxygen CAS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria are those patients attending for a screening colonoscopy through the Bowel Cancer Screening Programme who wish to start their colonoscopy with Entonox® alone. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 128

Exclusion criteria

Exclusion criteria: The exclusion criteria are the usual contraindications to the use of Entonox® which include; severe respiratory disease, bullous emphysema, pneumothorax, middle ear disease, sinusitis and recent head injury and previous intolerance. Other exclusion criteria are a history of previous colectomy / colonic resection, and refusal to enter the trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: Does continuous use of Entonox® reduce pain severity during colonoscopy?; Secondary Objective: Does continuous use of Entonox® during colonoscopy increase side effects compared to as required? Does continuous use of Entonox® during colonoscopy increase patient satisfaction? Does continuous use of Entonox® during colonoscopy increase willingness to have a repeat colonoscopy? Does continuous use of Entonox® during colonoscopy reduce the need for additional analgesia? ;Primary end point(s): The primary outcome measure will be the recollection of pain during colonoscopy when asked prior to leaving the endoscopy department. Prior to leaving patients will be asked the standard question of ‘between 0 and 10, on average, how much pain have you had during the colonoscopy?’;Timepoint(s) of evaluation of this end point: The time point for this is prior to the patient leaving the endoscopy department.	—

Measure

Time frame

Main Objective: Does continuous use of Entonox® reduce pain severity during colonoscopy?; Secondary Objective: Does continuous use of Entonox® during colonoscopy increase side effects compared to as required? Does continuous use of Entonox® during colonoscopy increase patient satisfaction? Does continuous use of Entonox® during colonoscopy increase willingness to have a repeat colonoscopy? Does continuous use of Entonox® during colonoscopy reduce the need for additional analgesia? ;Primary end point(s): The primary outcome measure will be the recollection of pain during colonoscopy when asked prior to leaving the endoscopy department. Prior to leaving patients will be asked the standard question of ‘between 0 and 10, on average, how much pain have you had during the colonoscopy?’;Timepoint(s) of evaluation of this end point: The time point for this is prior to the patient leaving the endoscopy department.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary end points will be: 1) Recollection of overall pain levels 2) Experience of pain during colonoscopy. 3) Willingness to have a repeat colonoscopy. 4) Overall satisfaction 5) need for additional analgesia or sedation 6) Side effects ; Timepoint(s) of evaluation of this end point: 1) Recollection of overall pain levels will be asked immediately following colonoscopy and 1-3 days following colonoscopy. 2) Patients experience of pain will be asked every 2 minutes during colonoscopy. The mean pain level, peak pain level and total (area under curve) will be calculated for each patient and treatment strategy. 3) Willingness to have a repeat colonoscopy will be asked prior to discharge and 1-3 days following the colonoscopy. 4)Overall patient satisfaction will be asked prior to discharge and 1-3 days following colonoscopy 5) Need for additional analgesia or sedation will be measured during colonoscopy. 6) The incidence of side effects will be monitored during and immediately after colonoscopy	—

Measure

Time frame

Secondary end point(s): Secondary end points will be: 1) Recollection of overall pain levels 2) Experience of pain during colonoscopy. 3) Willingness to have a repeat colonoscopy. 4) Overall satisfaction 5) need for additional analgesia or sedation 6) Side effects ; Timepoint(s) of evaluation of this end point: 1) Recollection of overall pain levels will be asked immediately following colonoscopy and 1-3 days following colonoscopy. 2) Patients experience of pain will be asked every 2 minutes during colonoscopy. The mean pain level, peak pain level and total (area under curve) will be calculated for each patient and treatment strategy. 3) Willingness to have a repeat colonoscopy will be asked prior to discharge and 1-3 days following the colonoscopy. 4)Overall patient satisfaction will be asked prior to discharge and 1-3 days following colonoscopy 5) Need for additional analgesia or sedation will be measured during colonoscopy. 6) The incidence of side effects will be monitored during and immediately after colonoscopy

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Countries

United Kingdom

Contacts

Public ContactJim Lithgow

Sheffield Teaching Hospitals NHS Foundation Trust

jim.lithgow@sth.nhs.uk01142265424

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026