Clinical Trial: Is Analgesic Effect of Low Dose Ketamine-midazolam the Same as Morphine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparing Low Dose IV Ketamine-midazolam Versus IV Morphine Regarding ED Pain Control in Patients Sustaining Closed Limb Fracture(s)

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Isfahan University of Medical Sciences

Current Primary Outcome: VAPS [ Time Frame: 30 minutes ]

the pain score was verified at the outset and every 10 minutes after administration of analgesics.


Original Primary Outcome: Same as current

Current Secondary Outcome: HR,RR,SPO2,BP [ Time Frame: 30 minutes ]

the variables were assessed for an interval of 30 minutes.


Original Secondary Outcome: Same as current

Information By: Isfahan University of Medical Sciences

Dates:
Date Received: February 21, 2013
Date Started: December 2012
Date Completion:
Last Updated: March 6, 2013
Last Verified: March 2013