Women require routine opioids to prevent painful colonoscopies: a randomised controlled trial.

BACKGROUND: Women are at high risk for painful colonoscopy. Pain, but also sedation, are barriers to colorectal cancer (CRC) screening participation. In a randomised controlled trial, we compared on-demand with pre-colonoscopy opioid administration to control pain in women at CRC screening age. METHODS: Women, aged 55-79 years, attending colonoscopy at two Norwegian endoscopy units were randomised 1:1:1 to (1) fentanyl on-demand, (2) fentanyl prior to colonoscopy, or (3) alfentanil on-demand. The primary endpoint was procedural pain reported by the patients on a validated four-point Likert scale and further dichotomized for the study into painful (moderate or severe pain) and non-painful (slight or no pain) colonoscopy. Secondary endpoints were: willingness to repeat colonoscopy, adverse events, cecal intubation time and rate, and post-procedure recovery time. RESULTS: Between June 2017 and May 2020, 183 patients were included in intention-to-treat analyses in the fentanyl on-demand group, 177 in the fentanyl prior to colonoscopy group, and 179 in the alfentanil on-demand group. Fewer women receiving fentanyl prior to colonoscopy reported a painful colonoscopy compared to those who were given fentanyl on-demand (25.2% vs. 44.1%, p < .001). There was no difference in the proportion of painful colonoscopies between fentanyl on-demand and alfentanil on-demand (44.1% vs. 39.5%, p = .40). No differences were observed for adverse events or any of the other secondary endpoints between the three groups. CONCLUSIONS: Fentanyl prior to colonoscopy provided better pain control than fentanyl or alfentanil on-demand. Fentanyl before colonoscopy should be recommended to all women at screening age. Trial registration: Clinicaltrials.gov (NCT01538550). Norwegian Medicines Agency (16/16266-13). EU Clinical Trials Register (EUDRACTNR. 2016-005090-13).

Psychological effects of colorectal cancer screening: Participants vs individuals not invited.

AIM: To investigate the possible long-term psychological harm of participating in colorectal cancer (CRC) screening in Norway. METHODS: In a prospective, randomized trial, 14294 participants (aged 50-74 years) were invited to either flexible sigmoidoscopy (FS) screening, or a faecal immunochemical test (FIT) (1:1). In total, 4422 screening participants (32%) completed the questionnaire, which consisted of the Hospital Anxiety and Depression Scale and the SF-12, a generic health-related quality of life (HRQOL) measurement, when invited to screening and one year after the invitation. A control group of 7650 individuals was invited to complete the questionnaire only, at baseline and one year after, and 1911 (25%) completed the questionnaires. RESULTS: Receiving a positive or negative screening result and participating in the two different screening modalities did not cause clinically relevant mean changes in anxiety, depression or HRQOL after one year. FS screening, but not FIT, was associated with an increased probability of being an anxiety case (score ≥ 8) at the one-year follow-up (5.6% of FS participants transitioned from being not anxious to anxious, while 3.0% experienced the reverse). This increase was moderately significantly different from the changes in the control group (in which the corresponding numbers were 4.8% and 4.5%, respectively), P = 0.06. CONCLUSION: Most individuals do not experience psychological effects of CRC screening participation after one year, while FS participation is associated with increased anxiety for a smaller group.