the pain score was verified at the outset and every 10 minutes after administration of analgesics.
Is Analgesic Effect of Low Dose Ketamine-midazolam the Same as Morphine
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.
Intervention / Treatment
-
Ketamine-Midazolam (DRUG)Ketamine 300-500mcg/kg plus midazolam 0.03 mg/kg once.
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Morphine (DRUG)morphine 0.05 mg/kg
Condition or Disease
- Closed Multiple Fractures of Upper and Lower Limbs
Phase
Study Design
Study type: | INTERVENTIONAL |
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Status: | Completed |
Study results: | No Results Available |
Age: | 18 Years to 60 Years |
Enrollment: | 236 (ACTUAL) |
Funded by: | Other |
Allocation: | Randomized |
Primary Purpose: | Treatment |
MaskingSINGLE:
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Clinical Trial Dates
Start date: | Dec 01, 2012 | |
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Primary Completion: | Jan 01, 2013 | ACTUAL |
Completion Date: | Feb 01, 2013 | ACTUAL |
Study First Posted: | Mar 08, 2013 | ESTIMATED |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Mar 06, 2013 |
Sponsors / Collaborators
Lead Sponsor:
Isfahan University of Medical Sciences
Responsible Party:
N/A
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.
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.
Participant Groups
-
300 to 500 mcg/kg ketamine plus 0.03 mg/kg midazolam
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0.05 to 0.1 mg/kg morphine
Eligibility Criteria
Sex: | All |
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Minimum Age: | 18 |
Maximum Age: | 60 |
Age Groups: | Adult |
Healthy Volunteers: | Yes |
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
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
Primary Outcomes
Secondary Outcomes
-
the variables were assessed for an interval of 30 minutes.
Other Outcomes
-
the patients were closely observed for any drug induced adverse events.
More Details
NCT Number: | NCT01807429 |
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Other IDs: | 390284 |
Study URL: | https://clinicaltrials.gov/study/NCT01807429 |
Last updated: Sep 29, 2023