| Methods |
Design: three group parallel trial
Purpose: evaluate the usefulness of premedication with an oral anticholinergic for relief of pain associated with barium enema |
| Participants |
Patients: patients undergoing a pain inducing medical procedure (barium enema)
Baseline comparability: NS |
| Interventions |
Placebo: tablet with no hyoscyamine 15 to 30 minutes before procedure
Untreated: no tablet
Experimental: tablet with hyoscyamine
(Co‐intervention: NS) |
| Outcomes |
Pain (0 to 10 analogue scale) reported immediately after enema Side effects |
| Notes |
Patients with contraindications to hyoscyamine were 'moved to the placebo and no‐treatment group'. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15 % |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
Low risk |
N = 70 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation NOT clearly concealed |
