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

Ketamine

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.
  • Morphine (DRUG)
    morphine 0.05 mg/kg

Condition or Disease

  • Closed Multiple Fractures of Upper and Lower Limbs

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 60 Years
    Enrollment: 236 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Dec 01, 2012
    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.

    Participant Groups

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

    • 0.05 to 0.1 mg/kg morphine

    Eligibility Criteria

    Sex: All
    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

    Primary Outcomes

    • the pain score was verified at the outset and every 10 minutes after administration of analgesics.

    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
    Other IDs: 390284
    Study URL: https://clinicaltrials.gov/study/NCT01807429
    Last updated: Sep 29, 2023