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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COMPLETED
PHASE3
125 participants
INTERVENTIONAL
2017-04-01
2018-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control (Placebo+ Standard of Care))
Placebo
Distilled water
Ketamine + Standard of Care
Ketamine
1 mg/kg intranasal ketamine
Fentanyl + Standard of Care
Fentanyl
1μg/kg intranasal fentanyl
Interventions
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Placebo
Distilled water
Ketamine
1 mg/kg intranasal ketamine
Fentanyl
1μg/kg intranasal fentanyl
Eligibility Criteria
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Inclusion Criteria
* lack of pregnancy
* no history of allergy to ketamine, fentanyl (or opioids), or acetaminophen,
* no history of liver diseases,
* no acute or chronic structural or functional nasal obstruction diseases,
* no history of drug or psychiatric addiction,
* no pain medication within the past four hours,
* no history of heart disease,
* and the presentation of the written consent to participate in the study.
Exclusion Criteria
* an elevated systolic blood pressure to higher than 180 mmHg,
* a decreased diastolic blood pressure to less than 80 mmHg,
* inability to understand the VAS pain rating system,
* symptoms of acute heart disease and respiratory depression (respiratory rate \<8 / min),
* and the patient's dissatisfaction to continue the cooperation in study
15 Years
65 Years
ALL
No
Sponsors
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Isfahan University of Medical Sciences
OTHER
Responsible Party
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Mehdi Nasr Isfahani
Dr.
Locations
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Al-Zahra University Hospital
Isfahan, , Iran
Countries
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Other Identifiers
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396828
Identifier Type: -
Identifier Source: org_study_id
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