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

NCT ID: NCT01807429

Last Updated: 2013-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-02-28

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ketamine-midazolam

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

Group Type: EXPERIMENTAL

Ketamine-midazolam

Intervention Type: DRUG

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

Morphine

0.05 to 0.1 mg/kg morphine

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

morphine 0.05 mg/kg

Interventions

Ketamine-midazolam

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

Intervention Type: DRUG

Morphine

morphine 0.05 mg/kg

Intervention Type: DRUG

Other Intervention Names

Ketaral; Avinza

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mehdi Nasr Isfahani

Mehdi Nasr Isfahani

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omid Ahmadi, professor

Role: STUDY_DIRECTOR

Isfahan University of Medical Sciences

Other Identifiers

390284

Identifier Type: -

Identifier Source: org_study_id