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

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Closed Multiple Fractures of Upper and Lower Limbs

Treatments: Drug: Morphine; Drug: Ketamine-midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01807429

390284

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

Ketamine-midazolam

Experimental group

Description:

300 to 500 mcg/kg ketamine plus 0.03 mg/kg midazolam

Treatment:

Drug: Ketamine-midazolam

Morphine

Active Comparator group

Description:

0.05 to 0.1 mg/kg morphine

Treatment:

Drug: Morphine