Comparing two treatments for shivering after cesarean delivery for labor dystocia under epidural anesthesia.
It is a double blinded randomized control trial. Study population: parturients undergoing a cesarean delivery for labor dystocia under epidural anesthesia experiencing shivering grade III or IV on the standardized shivering scale of Crossley and Mahajan Experimental group: dexmedetomidine 0.35 mcg/kg IV in 2 minutes Control group: meperidine 0.35 mg/kg IV in 2 minutes Primary outcome : Time to stop level III and IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug Secondary outcome: Response rate, incidence of nausea, vomiting, hypotension, bradycardia, maternal satisfaction and a cost-benefit analysis. The hypothesis is that dexmedetomidine will act faster, will have a superior response rate with less adverse effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Stop time
Time to stop class III or IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug (meperidine versus dexmedetomidine)
Time frame: 15 minutes
incidence of adverse effects
sedation, nausea, vomiting, hypotension and bradycardia
Time frame: 24 hours
maternal satisfaction
satisfaction (yes or no) regarding experience with study drug
Time frame: at 24 hours
response rate
percentage of patient responding when the drug is given
Time frame: 15 minutes
cost benefice analysis
comparing cost of the drug
Time frame: 24 hours
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