Arambasik 2013.
Methods |
Allocation: randomized Controlled: placebo and active comparator Blinding: double‐blind Arm: 2‐arm, parallel treatment group, pilot study Centre: single centre Study dates and duration: 16‐month period trial (June 2011 to October 2012) |
|
Participants |
Inclusion criteria: not reported Exclusion criteria: not reported Baseline characteristics N: 37 participants; 37 VOC episodes Age (mean): 29.9 years Gender: F 13, M 24 Number randomized: 17 intervention, 20 control Number completed: number of participants at each follow‐up time not explicitly stated Setting of recruitment and treatment: not reported Country and sites: Akron General Medical Centre, Akron, OH, USA |
|
Interventions |
Duration of treatment: individual time to resolution of crisis Follow‐up period: not reported Treatment group (17 participants; 17 VOC episodes):
Control group (20 participants; 20 VOC episodes):
Cointerventions/additional analgesia: not reported |
|
Outcomes |
Primary outcomes
Secondary outcomes
|
|
Notes | Abstract only, sufficient data on pain scores Sources of funding: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "this pilot study was randomised, prospective, double‐blinded trial." Comment: unclear details of randomization. |
Allocation concealment (selection bias) | Unclear risk |
Quote: "this pilot study was randomised, prospective, double‐blinded trial." Comment: unclear details of concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk |
Quote: "this pilot study was... double‐blind..." Comment: insufficient information, unclear method of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information from abstract. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: insufficient information from abstract. |
Selective reporting (reporting bias) | Unclear risk | Comment: primary outcome was reported in methods and results. However, unclear what other outcomes were from this abstract alone. |
Size | High risk | Comment: total 37 participants, fewer than 50 participants per treatment arm. |
Other bias | Unclear risk | Comment: unclear due to only abstract available. |