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. 2019 Nov 19;2019(11):CD012187. doi: 10.1002/14651858.CD012187.pub2

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):
  • IV hydromorphone 2 mg

  • 15 minutes later: IV hydromorphone 2 mg + IV ketamine 6.2 mg/kg


Control group (20 participants; 20 VOC episodes):
  • IV hydromorphone 2 mg

  • 15 minutes later: IV hydromorphone 2 mg + IV saline placebo 6.2 mg/kg


Cointerventions/additional analgesia: not reported
Outcomes Primary outcomes
  • Pain score (VAS 0–10)


Secondary outcomes
  • Not reported

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.