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

Phase 2

Completed

• Conditions: Closed Multiple Fractures of Upper and Lower Limbs
• Interventions: Drug: Ketamine-midazolam; Drug: Morphine

• Registration Number: NCT01807429
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Study First Submitted: 2013-02-21
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-06
• Last Update Submitted: 2013-03-06
• Study First Posted: 2013-03-08
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine-midazolam	Ketamine-midazolam	300 to 500 mcg/kg ketamine plus 0.03 mg/kg midazolam
Morphine	Morphine	0.05 to 0.1 mg/kg morphine

Primary Outcome Measures

Name	Time	Method
VAPS	30 minutes	the pain score was verified at the outset and every 10 minutes after administration of analgesics.

Secondary Outcome Measures

Name	Time	Method
HR,RR,SPO2,BP	30 minutes	the variables were assessed for an interval of 30 minutes.