| Methods |
Design: eight group parallel trial
Purpose: examine the effect of placebo and proglumide on postoperative pain |
| Participants |
Patients: postoperative in‐patients after thoracotomy
Baseline comparability: yes (pain intensity) |
| Interventions |
Placebo: open infusion of saline
Untreated: hidden infusion of saline
Experimental:
‐open infusion of proglumide (0.05 mg, 0.5 mg, 5 mg)
‐hidden infusion of proglumide (0.05 mg, 0.5 mg, 5 mg)
(Co‐intervention: NS) |
| Outcomes |
Pain (VAS) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'double‐blind randomized study' |
| 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? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
High risk |
N = 24 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
