Is Analgesic Effect of Low Dose Ketamine-midazolam the Same as Morphine
Information source: Isfahan University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Closed Multiple Fractures of Upper and Lower Limbs
Intervention: Ketamine-midazolam (Drug); Morphine (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Isfahan University of Medical Sciences Official(s) and/or principal investigator(s):
Omid Ahmadi, professor, Study Director, Affiliation: Isfahan University of Medical Sciences
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.
Clinical Details
Official title: Comparing Low Dose IV Ketamine-midazolam Versus IV Morphine Regarding ED Pain Control in Patients Sustaining Closed Limb Fracture(s)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: VAPS
Secondary outcome: HR,RR,SPO2,BP
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: December 2012
Last updated: March 6, 2013
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