Reducing painful visual examinations of the large intestine in women who are attending in a bowel cancer screening program

Reducing painful colonoscopies in women participating in a colorectal cancer screening program: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005090-13-NO

Enrollment

420

Registered

2017-01-10

Start date

2017-04-18

Completion date

Unknown

Last updated

2022-03-02

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

Conditions

Many women are experiencing pain under colonoscopy. The present study aims to reduce pain in women undergoing colonoscopy in a bowel cancer screening program in Norway.

Interventions

Trade Name: Fentanyl Pharmaceutical Form: Solution for injection/infusion Trade Name: Rapifen Pharmaceutical Form: Solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All women attending colonoscopy in the Bowel cancer screening in Norway (BCSN) are eligible for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250

Exclusion criteria

Exclusion criteria: Exclusion criteria are identical to those in BCSN: Potential exclusion criteria are: Former open colon/rectum surgery; individuals in chronic need of care; ongoing chemo- or radiotherapy for malignant disease; chronic heart-/lung disease NYHA III-IV; individuals with heart valve implant and lifelong anticoagulation; coronary attack with need for hospitalization within the last 3 months; cerebrovascular event within the last 3 months; domiciled outside the screening area; in addition allergy to Fentanyl or Rapifen

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the present trial is firstly to evaluate whether Fentanyl administrated prior to colonoscopy is associated with a lower risk of moderate or severe pain as compared to Fentanyl given on demand, to women undergoing colonoscopy; secondly to evaluate whether Rapifen on demand is associated with a lower risk of moderate or severe pain compared to Fentanyl given on demand, to women undergoing colonoscopy.;Secondary Objective: Secondary objectives are to obtain better pasient satisfaction and willingness to participate in bowel cancer screening.;Primary end point(s): The primary endpoint is the pain score on a 4 point Likert scale and will be registered at the end of the examination. Additionally assessment of pain will be performed on a 100 mm VAS scale on an additional form when reaching the splenic flexure and the cecum as well as immediately prior to analgesia in the two arms receiving analgesia on demand. In the presence of severe pain they are informed to give a sign to the endoscopy staff.;Timepoint(s) of evaluation of this end point: At the end of the examination	—

Measure

Time frame

Main Objective: The aim of the present trial is firstly to evaluate whether Fentanyl administrated prior to colonoscopy is associated with a lower risk of moderate or severe pain as compared to Fentanyl given on demand, to women undergoing colonoscopy; secondly to evaluate whether Rapifen on demand is associated with a lower risk of moderate or severe pain compared to Fentanyl given on demand, to women undergoing colonoscopy.;Secondary Objective: Secondary objectives are to obtain better pasient satisfaction and willingness to participate in bowel cancer screening.;Primary end point(s): The primary endpoint is the pain score on a 4 point Likert scale and will be registered at the end of the examination. Additionally assessment of pain will be performed on a 100 mm VAS scale on an additional form when reaching the splenic flexure and the cecum as well as immediately prior to analgesia in the two arms receiving analgesia on demand. In the presence of severe pain they are informed to give a sign to the endoscopy staff.;Timepoint(s) of evaluation of this end point: At the end of the examination

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Secondary

Measure	Time frame
Secondary end point(s): Pain score on 100 mm visual analogue scale (VAS). Use/dose of medication. Willingness to repeat colonoscopy. Complications. Adverse effects of medication. Cecal intubation time. Time elapsed between the end of the colonoscopy and the discharge from the endoscopy unit.;Timepoint(s) of evaluation of this end point: At the end of the examination and when the patient is sending a questionnaire the day after the examination	—

Measure

Time frame

Secondary end point(s): Pain score on 100 mm visual analogue scale (VAS). Use/dose of medication. Willingness to repeat colonoscopy. Complications. Adverse effects of medication. Cecal intubation time. Time elapsed between the end of the colonoscopy and the discharge from the endoscopy unit.;Timepoint(s) of evaluation of this end point: At the end of the examination and when the patient is sending a questionnaire the day after the examination

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Countries

Norway

Contacts

Public ContactTarmkreftscreening

Cancer Registry of Norway

anna.schult@kreftregisteret.no

Outcome results

None listed

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