| Methods |
Design: three group parallel trial
Purpose: examine the effect of zolpidem on postoperative pain |
| Participants |
Patients: out‐patients undergoing knee arthroscopy
Baseline comparability: yes (age, gender, preoperative pain score) |
| Interventions |
Placebo: gelatin pills with no zolpidem
Untreated: no pills
Experimental: pills with zolpidem
(Co‐intervention: yes (ibuprofen + hydrocodone/acetaminophen)) |
| Outcomes |
Pain (0 to 10 VAS; mean daily postoperative)
Pain (mean morning and evening postoperative)
Fatigue (0 to 10 VAS; mean daily postoperative)
Fatigue (mean morning and evening postoperative) |
| 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 |
'... the surgeon was unaware if the patient was given zolpidem or placebo' |
| 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? |
High risk |
N = 43 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
