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

March 6, 2013 updated by: Mehdi Nasr Isfahani, Isfahan University of Medical Sciences

Comparing Low Dose IV Ketamine-midazolam Versus IV Morphine Regarding ED Pain Control in Patients Sustaining Closed Limb Fracture(s)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

236

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine-midazolam
300 to 500 mcg/kg ketamine plus 0.03 mg/kg midazolam
Drug: Ketamine-midazolam
Ketamine 300-500mcg/kg plus midazolam 0.03 mg/kg once.
Other Names:
  • Ketaral
Active Comparator: Morphine
0.05 to 0.1 mg/kg morphine
Drug: Morphine
morphine 0.05 mg/kg
Other Names:
  • Avinza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAPS
Time Frame: 30 minutes
the pain score was verified at the outset and every 10 minutes after administration of analgesics.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HR,RR,SPO2,BP
Time Frame: 30 minutes
the variables were assessed for an interval of 30 minutes.
30 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse drug effects
Time Frame: 30 minutes
the patients were closely observed for any drug induced adverse events.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Study Director: Omid Ahmadi, professor, Isfahan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Estimate)

March 8, 2013

Last Update Submitted That Met QC Criteria

March 6, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 390284

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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