NCT01807429

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Isfahan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Closed Multiple Fractures of Upper and Lower Limbs

Interventions

Type	Name	Description
DRUG	Ketamine-midazolam	Ketamine 300-500mcg/kg plus midazolam 0.03 mg/kg once.
DRUG	Morphine	morphine 0.05 mg/kg

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2013-03-08
• Last updated: 2013-03-08