Comparison Study of Analgesic Effects for Dexmedetomidine-fentanyl vs Dexmedetomidine-ketamine in Femur Proximal Fracture Patients
Phase: NA
Conditions: Pain
Sponsor: Inje University

ID:2014-027 
Dexmedetomidine-ketamine in Femur Proximal Fracture Patients 
NCT02150759 
04-24-2019 
This study was approved by the institutional review board of Inje University Haeundae Paik 
Hospital (129792-2014-027) and written informed consent was obtained from patients. This 
study was registered before patient enrollment began at ClinicalTrials.gov (NCT02150759; 
date of registration: December 23, 2013). 
We hypothesized that ketamine or fentanyl could be better analgesics to control movement 
evoked pain in elderly patients with proximal femur fracture who were undergoing DEX 
continuous infusion. 
We compared the analgesic effect of Dexmedetomidine (1mcg/kg)- fentanyl (1mcg/kg) 
combination vs dexmedetomidine (1mcg/kg) - ketamine (1mg/kg) combination. After 10 
minutes of drug infusion, patients are prepared for spinal anesthesia. Pain scale and quality of 
patient during lateral positioning for spinal anesthesia were measured three times (lateral 
position, chest-knee position, intrathecal local anesthetics injection) 
Pain score (0 = calm, 1 = facial grimacing, 2 = moaning, 3 = screaming, 4 = unable to 
proceed because of restlessness or agitation) of patient position maintained for spinal block 
was recorded. Quality score (0 = not satisfactory, 1 = satisfactory, 2 = good, and 3 = optimal) 
of patient position maintained for spinal block was recorded. Data are presented as the 
number of patients. 
Data were analyzed using Medcalc 14.12.0 (MedCalc Software bvba, Ostend, Belgium). 
Parametric variables were described as mean ± standard deviation (SD). Qualitative variables 
were described as number and as median (interquartile range). Student’s t-test, Fisher’s exact 
test, or Mann-Whitney U-test was used as appropriate to compare the two groups. P < 0.05 
was considered to indicate statistical significant. 
 
  
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