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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Closed Multiple Fractures of Upper and Lower Limbs

Intervention / Treatment
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* Drug: Ketamine-midazolam
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 and 60 years Patients with closed limb fracture(s) VAS score of at least 6 Exclusion Criteria: Acute pulmonary infection Previous coronary artery diseases,ACS,congestive heart failure, suspected aortic dissection History of uncontrolled hypertention or blood pressure > 140/90mmHg Brain injury with focal neurological deficit or loss of consciousness Central nervous system mass lesion,hydrocephalus, or other states with increased intracranial pressure Glaucoma and acute globe injury History of porphyria Previous hyperthyroidism or thyroid hormone replacement Pregnancy or laction Major psychiatric disorder Previous allergic reaction to the agents administered in the study Patient declined to provide written informed conse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine-midazolam<br>300 to 500 mcg/kg ketamine plus 0.03 mg/kg midazolam | Drug: Ketamine-midazolam<br>* Ketamine 300-500mcg/kg plus midazolam 0.03 mg/kg once.<br>* Other names: Ketaral;|
| Active Comparator: Morphine<br>0.05 to 0.1 mg/kg morphine | Drug: Morphine<br>* morphine 0.05 mg/kg<br>* Other names: Avinza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAPS | the pain score was verified at the outset and every 10 minutes after administration of analgesics. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HR,RR,SPO2,BP | the variables were assessed for an interval of 30 minutes. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine,, Midazolam,, Morphine,, visual analogue score