| Methods |
Design: three group parallel trial
Purpose: examine the influence of hidden infusion of naloxone on the effect of fentanyl and placebo in acute pain |
| Participants |
Patients: postoperative in‐patients after extraction of molars
Baseline comparability: NS |
| Interventions |
Placebo: injection with saline
Untreated: no injection
Experimental: injection with fentanyl
(Co‐intervention: pre‐treatment hidden infusion of either naloxone or naloxone vehicle) |
| Outcomes |
Pain (McGill pain rating index) |
| Notes |
The trial report does not explicitly state that allocation was random, however personal communication with authors established that this is likely to have been the case. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'random table generated by a shuffle program' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'Hidden infusions of naloxone (10 mg) or naloxone vehicle were administered double‐blind...' |
| 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 = 29 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
