A Phase 2/3 interventional study of Ketamine-midazolam and Morphine in Closed Multiple Fractures of Upper and Lower Limbs, sponsored by Isfahan University of Medical Sciences. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-08.
Sponsored by Isfahan University of Medical Sciences · Phase 2/3, Interventional, and Treatment
the investigators assessed the effects of low-dose IV ketamine-midazolam versus morphine on pain control in trauma patients with closed limb fracture(s); and also compared the incidence of adverse events (mainly cardio pulmonary ) between two groups.
this prospective, single blind, noninferiority trial randomized consecutive ED patients aged 18 to 60 years to two groups: receiving either 300-500 mcg ketamine plus 0.03 mg midazolam, or 0.05 to 0.1 mg morphine. Visual analogue score and adverse events were carefully verified during an interval of 30 minutes.
Two hundreds, thirty six patients were selected, among whom were 207 males (87.3%), and 29 females (12.2%). The average age was 29±2, with extremes of 60 years and 18 years.the patients were divided into two groups: G1: 116 patients receiving ketamine-midazolam and G2: 120 patients receiving morphine alone.
Exclusion Criteria:
300 to 500 mcg/kg ketamine plus 0.03 mg/kg midazolam
Drug: Ketamine-midazolam
0.05 to 0.1 mg/kg morphine
Drug: Morphine
Ketamine 300-500mcg/kg plus midazolam 0.03 mg/kg once.
Also known as: Ketaral
morphine 0.05 mg/kg
Also known as: Avinza
VAPS
the pain score was verified at the outset and every 10 minutes after administration of analgesics.
Time frame: 30 minutes
HR,RR,SPO2,BP
the variables were assessed for an interval of 30 minutes.
Time frame: 30 minutes
adverse drug effects
the patients were closely observed for any drug induced adverse events.
Time frame: 30 minutes
No study locations are listed for this record.
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Isfahan University of Medical Sciences