| Methods |
Design: three group parallel trial
Purpose: examine the effect of placebo medication and naloxone on acute pain |
| Participants |
Patients: postoperative in‐patients after extraction of molars
Baseline comparability: NS |
| Interventions |
Placebo: injection with naloxone vehicle
Untreated: no injection
Experimental: injection with naloxone
(Co‐intervention: NS) |
| Outcomes |
Pain |
| Notes |
Data reported in a way not extractable for meta‐analysis. Original data lost (personal communication Gracely RH) |
| 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 |
'Two groups of 12 subjects received double‐blind intravenous injections of either 10mg naloxone or naloxone vehicle (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? |
High risk |
No protocol available. Data reported in a way not extractable for meta‐analysis. Original data lost (personal communication Gracely RH) |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
High risk |
N = 24 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
