Low-Dose Intravenous Ketamine Bolus Versus Conventional Technique
NCT ID: NCT03499886
Last Updated: 2018-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
198 participants
INTERVENTIONAL
2017-01-17
2018-05-14
Brief Summary
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Materials and Methods: In this randomized clinical trial, 198 participants with upper and lower extremity fractures were enrolled. The participants were divided randomly into two groups. In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds. Then outcomes such as sedation depth and complications were measured for every two minutes and satisfaction of participants and physicians were recorded.
Results: Results showed that the successful sedation rate in the low dose ketamine group was significantly lower, as compared to the control group (7% vs 100%) (p\<0.001). Moreover, In terms of duration of drug effect and of recovery, the low dose ketamine group were significantly lower compared with the group receiving higher dosage of ketamine (p\<0.05). Furthermore, the sedation depth based on Wisconsin Sedation Scale was significantly higher, in the low dose ketamine group compared to the other group. By evaluating different complications, we found that the rate of neurological (20.4 % vs 5%) and physiological (10.2% vs 2%) complications in the control group was significantly higher compared to the group receiving low-dose ketamine (p\<0.05).
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Detailed Description
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Exclusion criteria consisted of patients' age \<3 months with the body temperature of \> 38 ̊C, due to upper respiratory tract infection. Patients having any other complications such as cardiovascular, gastrointestinal, psychological and neurological were excluded from the study. We also excluded the patients who have withdrawn from the study.
Participants and Intervention The study flowchart is shown in figure 1. Two hundreds ten patients with a diagnosis of upper and lower extremity fractures, diagnosed by Emergency Medicine Specialist, were enrolled based on clinical and para-clinical images and inclusion criteria.
The participants were randomly allocated into two groups, using a block randomization procedure with matching subjects in each block based on sex and age. One hundred ninety eight patients completed the study; including one hundred from the intervention group and 98 from the control group. The study received ethics approval from the Ethics Committee of Isfahan University of Medical Sciences (--------------), and all participants and their parents signed the informed consent form.
After obtaining informed consent, eligible patients were enrolled. All patients were monitored by direct observation and continuous cardiovascular monitoring, in order to check the vital signs and also by pulse Oximeters to examine the blood oxygen saturation level.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ketamine Hydrochloride 50Mg/1mL
In the intervention group, "Ketamine Hydrochloride 50Mg/1mL" was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds). Patient assessment was performed before and two minutes after ketamine injection, and then every 5 minutes after the reduction of the fracture, by an anesthetist blind to the type of intervention.
Ketamine Hydrochloride 50Mg/1mL Solution for Injection
In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds.
Ketamine Hydrochloride 50Mg/mL
in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds. Patient assessment was performed before and two minutes after ketamine injection, and then every 5 minutes after the reduction of the fracture, by an anesthetist blind to the type of intervention.
Ketamine Hcl 50Mg/Ml Inj
In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds.
Interventions
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Ketamine Hydrochloride 50Mg/1mL Solution for Injection
In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds.
Ketamine Hcl 50Mg/Ml Inj
In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) within the normal range
* Having age of 6 months to 17 years
* Requiring a reduction of upper and lower limb fractures.
* Subjects who did not complete study endpoints, however, were included as part on an intention to treat analysis.
Exclusion Criteria
* Body temperature of \> 38 ̊C, due to upper respiratory tract infection.
* Participants having any other complications such as cardiovascular, gastrointestinal, psychological and neurological .
* Patients who have withdrawn from the study, or those receiving benzodiazepines and other sedative drugs within 6 hours prior to enrollment.
* Subjects who refused to give consent or those who were judged by investigator as non eligible were excluded as well.
6 Months
17 Years
ALL
Yes
Sponsors
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Isfahan University of Medical Sciences
OTHER
Responsible Party
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Mehdi Nasr Isfahani
Principal Investigator
Principal Investigators
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Mehdi Nasr Isfahani, M.D.
Role: PRINCIPAL_INVESTIGATOR
Isfahan University of Medical Sciences
Locations
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Al-Zahra University Hospital
Isfahan, , Iran
Mehdi Nasr Isfahani
Isfahan, , Iran
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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195027
Identifier Type: -
Identifier Source: org_study_id
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