Closed Multiple Fractures of Upper and Lower LimbsPhase 2/3NCT01807429
Is Analgesic Effect of Low Dose Ketamine-midazolam the Same as Morphine
A Phase 2/3 study testing Ketamine-midazolam and Morphine in people with Closed Multiple Fractures of Upper and Lower Limbs, run by Isfahan University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Closed Multiple Fractures of Upper and Lower Limbs
- What is being tested?
- Ketamine-midazolam and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Feb 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 60 years
- Patients with closed limb fracture(s)
- VAS score of at least 6
Who cannot join
- 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
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- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Ketamine-midazolam, Morphine
- Keywords
- Ketamine,, Midazolam,, Morphine,, visual analogue score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine-midazolamDrug
Also called Ketaral
Ketamine 300-500mcg/kg plus midazolam 0.03 mg/kg once.
MorphineDrug
Also called Avinza
morphine 0.05 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Ketamine-midazolam | Experimental | 300 to 500 mcg/kg ketamine plus 0.03 mg/kg midazolam Receives: Drug: Ketamine-midazolam |
| Morphine | Active comparator | 0.05 to 0.1 mg/kg morphine Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAPS
the pain score was verified at the outset and every 10 minutes after administration of analgesics.
Measured: 30 minutes
Secondary outcomes (1)
HR,RR,SPO2,BP
the variables were assessed for an interval of 30 minutes.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed Multiple Fractures of Upper and Lower LimbsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Nasr Isfahani, Isfahan University of Medical Sciences
- Investigators
- Omid Ahmadi, professor, Study director, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807429
- Sponsor's protocol ID
- 390284
- Status last verified
- Mar 2013
- First submitted
- 21 Feb 2013
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Low Dose IV Ketamine-midazolam Versus IV Morphine Regarding ED Pain Control in Patients Sustaining Closed Limb Fracture(s)
- ClinicalTrials.gov ID
- NCT01807429
- Acronym / sponsor ID
- 390284
- Keywords
- Ketamine,, Midazolam,, Morphine,, visual analogue score
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine-midazolam | Experimental | Drug: Ketamine-midazolam300 to 500 mcg/kg ketamine plus 0.03 mg/kg midazolam |
| Morphine | Active comparator | Drug: Morphine0.05 to 0.1 mg/kg morphine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between 18 and 60 years
- Patients with closed limb fracture(s)
- VAS score of at least 6
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine-midazolamAlso: KetaralKetamine 300-500mcg/kg plus midazolam 0.03 mg/kg once. | Drug | Ketamine-midazolam |
| MorphineAlso: Avinzamorphine 0.05 mg/kg | Drug | Morphine |
Primary outcome
VAPS
Time frame: 30 minutes
the pain score was verified at the outset and every 10 minutes after administration of analgesics.
1 secondary outcome
HR,RR,SPO2,BP
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omid Ahmadi, professor study director
Isfahan University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine-midazolam and Morphine in people with Closed Multiple Fractures of Upper and Lower Limbs, run by Isfahan University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAPS (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2013.