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OpenTrials
Completed

NCT Number: NCT01807429

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 18 and 60 years
  • Patients with closed limb fracture(s)
  • VAS score of at least 6

Exclusion criteria

  • Acute pulmonary infection
  • Previous coronary artery diseases,ACS,congestive heart failure,
  • suspected aortic dissection
  • History of uncontrolled hypertention or blood pressure > 140/90mmHg
  • Brain injury with focal neurological deficit or loss of consciousness
  • Central nervous system mass lesion,hydrocephalus, or other states with increased intracranial pressure
  • Glaucoma and acute globe injury
  • History of porphyria
  • Previous hyperthyroidism or thyroid hormone replacement
  • Pregnancy or laction
  • Major psychiatric disorder
  • Previous allergic reaction to the agents administered in the study
  • Patient declined to provide written informed conse

Treatment and study plan

Ketamine-midazolam

Drug

Ketamine 300-500mcg/kg plus midazolam 0.03 mg/kg once.

Other names: Ketaral

Morphine

Drug

morphine 0.05 mg/kg

Other names: Avinza

Primary outcomes

  1. VAPS

    Time frame: 30 minutes

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

Secondary outcomes

  1. HR,RR,SPO2,BP

    Time frame: 30 minutes

    the variables were assessed for an interval of 30 minutes.

Other outcomes

  1. adverse drug effects

    Time frame: 30 minutes

    the patients were closely observed for any drug induced adverse events.

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2013
Registry last updated
Mar 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.