| Methods |
Design: three group parallel trial
Purpose: examine the effect of fentanyl and placebo on the pain related to abortion |
| Participants |
Patients: women undergoing abortion
Baseline comparability: yes |
| Interventions |
Placebo: saline injections
Untreated: no injections
Experimental: fentanyl injections
(Co‐intervention: ibuprofen or acetaminophen, and lorazepam) |
| Outcomes |
Pain (11 point numerical pain scale, 0 to 10) after removal of speculum |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Low risk |
'sequentially numbered, opaque envelopes' |
| Blinding?
Treatment provider |
Low risk |
'Physicians, clinic staff, and women in the study did not know the contents of the syringes' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
Low risk |
N = 185 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
