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

Figures & data

Figure 1. Flowchart medication. BPM = Blood pressure measurement. Curved arrows = Strategies to repeat medication if required.

Table 1. Baseline participants’ characteristics in the three groups; fentanyl on-demand (the reference), fentanyl prior to colonoscopy or alfentanil on-demand.

	Fentanyl on-demand (n = 183)	Fentanyl prior (n = 177)	Alfentanil on-demand (n = 179)
Age, mean (95% CI), years	66.8 (65.9–67.7)	66.7 (65.8–67.5)	67.1 (66.2–67.9)
Heart rate (pre-procedure), mean (95% CI), beats per minute	75.8 (73.8–77.7)	74.9 (73.0–76.8)	75.0 (73.1–76.9)
Oxygen saturation (pre procedure), mean (95 % CI),%	97.1 (96.8–97.4)	97.0 (96.7–97.3)	96.8 (96.5–97.1)
Adequate bowel cleansing, n (%)^a	165/181 (91.2)	161/175 (92.0)	162/176 (92.1)
Body mass index, mean (95% CI), kg/m²	26.0 (25.3–26.8)	26.5 (25.7–27.3)	26.4 (25.6–27.2)
Expectation painful colonoscopy, n/N (%)	89/152 (58.6)	88/159 (55.4)	96/161 (59.6)
Previous painful colonoscopy, n/N (%)^b	34/58 (58.6)	44/77 (57.1)	49/69 (71.0)
Previous abdominal surgery, n/N (%)	96/161 (59.6)	91/159 ( 57.2)	86/168 (51.2)
Previous diverticulitis, n/N (%)	9/157 (5.7)	12/156 (7.7)	7/164 (4.3)
IBS with pain, n/N (%)	12/152 (7.9)	9/151 (6.0)	14/159 (8.8)
VAS before colonoscopy, mean (95% CI), mm	0.5 (0.3–0.7)	0.3 (0.2–0.4)	0.3 (0.2–0.5)

IBS: irritable bowel syndrome; VAS: visual analogue scale.

^aJudged as good/adequate or BBPs ≥2 in each segment.

^bOnly among those who reported a previous colonoscopy.

Figure 2. Flowchart trial.

Figure 3. Outcomes in the fentanyl on-demand group (the reference) compared to fentanyl prior to colonoscopy and alfentanil on-demand. ^ap < .001. Painful colonoscopy = moderate or severe pain. Serious adverse event = Systolic blood pressure < 100 mmHg and/or heart rate < 50 beats per minute and/or oxygen saturation < 90% without supplemental oxygen.

Table 2. Colonoscopy variables in participants of the three groups; fentanyl on-demand (the reference), fentanyl prior to colonoscopy or alfentanil on-demand.

	Fentanyl on-demand (n = 183)	Fentanyl prior (n = 177)	P^a	Alfentanil on-demand (n = 179)	P^a
Questionnaire response rate
1^st post-colonoscopy day, n/N (%)	161/183 (88.0)	151/177 (85.3)	.46	162/179 (90.5)	.44
Procedural pain score, recorded 1^st post-colonoscopy day, Likert scale
No pain, n/N (%)	33/161 (20.5)	59/151 (39.1)	<.001	38/162 (23.5)	.83
Slight pain, n/N (%)	57/161 (35.4)	54/151 (35.8)		60/162 (37.0)
Moderate pain, n/N (%)	46/161 (28.6)	20/151 (13.3)		40/162 (24.7)
Severe pain, n/N (%)	25/161 (15.5)	18/151 (11.9)		24/162 (14.8)
Completeness of colonoscopy
Cecal intubation rate, n/N (%)^b	159/179 (88.8)	160/175 (91.4)	.41	166/176 (94.3)	.06
Cecal intubation time, mean (95% CI), minutes	17.3 (15.8–19.1)	15.6 (14.2–17.1)	.11	17.5 (15.6–19.1)	.91
Medication
Analgesics given, n/N (%)	102/183 (55.7)	175/177 (98.9)	<.001	95/179 (53.1)	.61
Administration of additional opioid dose, n/N (%)	30/183 (16.4)	39/177 (22.0)	.17	40/179 (22.4)	.15
Dose, mean (95%CI), mcg (fentanyl)/ mg (alfentanil)	59.8 (51.3.5–68.3)	107.8 (103.4–112.2)	<.001	0.3 (0.3–0.4)	–
Dose in medicated persons, mean (95%CI), mcg (fentanyl)/ mg (alfentanil)	107.3 (101.1–113.5)	109.0 (104.9–113.1)	.63	0.68 (0.63–0.73)	–
Adverse events
Adverse events, n/N (%)^c	13/183 (7.1)	21/177 (11.9)	.12	16/179 (8.9)	.52
Serious adverse events, n/N (%)^d	5/183 (2.7)	6/177 (3.4)	.72	5/179 (2.8)	1.00

^aCompared to Fentanyl on-demand.

^bSwitching to small-calibre colonoscope or administering of benzodiazepine during examination was defined as intubation failure even if cecum was reached.

^cEvents requiring intravenous antiemetics, intravenous fluids, intravenous spasmolytics, elevating lower extremities.

^dSystolic blood pressure < 100 mmHg and/or heart rate < 50 beats per minute and/or oxygen saturation < 90% without supplemental oxygen.