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

Isfahan University of Medical Sciences236 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

236

Conditions

Closed Multiple Fractures of Upper and Lower Limbs

Interventions

Ketamine-midazolamDRUG

Ketamine 300-500mcg/kg plus midazolam 0.03 mg/kg once.

MorphineDRUG

morphine 0.05 mg/kg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Between 18 and 60 years 2. Patients with closed limb fracture(s) 3. VAS score of at least 6 Exclusion Criteria: 1. Acute pulmonary infection 2. Previous coronary artery diseases,ACS,congestive heart failure, 3. suspected aortic dissection 4. History of uncontrolled hypertention or blood pressure \> 140/90mmHg 5. Brain injury with focal neurological deficit or loss of consciousness 6. Central nervous system mass lesion,hydrocephalus, or other states with increased intracranial pressure 7. Glaucoma and acute globe injury 8. History of porphyria 9. Previous hyperthyroidism or thyroid hormone replacement 10. Pregnancy or laction 11. Major psychiatric disorder 12. Previous allergic reaction to the agents administered in the study 13. Patient declined to provide written informed conse

Outcomes

Primary Outcomes

VAPS

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

Time frame: 30 minutes

Secondary Outcomes

HR,RR,SPO2,BP

the variables were assessed for an interval of 30 minutes.

Time frame: 30 minutes

Data from ClinicalTrials.gov

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