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Intranasal Ketamine Versus Intranasal Fentanyl

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04414800
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Mehdi Nasr Isfahani, Isfahan University of Medical Sciences

Brief Summary:
Abstract Background: Given the inadequate control of pain in patients with injury that refer to the emergency departments, the rapid onset of action of intranasal administration in pain management, and the avoidance of administering opioid medications, the present study aimed at evaluating the effect of intranasal ketamine versus intranasal fentanyl on pain management in isolated traumatic patients Materials and Methods: The current study was performed on 125 patients that were divided into the following three groups: control group (n = 41), 1 mg/kg intranasal ketamine group (n = 40), and 1μg/kg intranasal fentanyl group (n = 44). Then pain scores, HR, RR, BP, and SaO2 were recorded at baseline, 5, 10, 15, 30, and 40 minutes after the intervention.

Condition or disease Intervention/treatment Phase
Multiple Trauma Pain, Acute Drug: Placebo Drug: Ketamine Drug: Fentanyl Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intranasal Ketamine Versus Intranasal Fentanyl on Pain Management in Isolated Traumatic Patients
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : April 15, 2018


Arm Intervention/treatment
Placebo Comparator: Control (Placebo+ Standard of Care)) Drug: Placebo
Distilled water

Active Comparator: Ketamine + Standard of Care Drug: Ketamine
1 mg/kg intranasal ketamine

Active Comparator: Fentanyl + Standard of Care Drug: Fentanyl
1μg/kg intranasal fentanyl




Primary Outcome Measures :
  1. Visual analogue score [ Time Frame: Change from baseline at 40 minutes ]
    a scale for measuring the extent of pain relief


Secondary Outcome Measures :
  1. Heart rate (HR) [ Time Frame: Change from baseline at 40 minutes ]
  2. Blood pressure (BP) [ Time Frame: Change from baseline at 40 minutes ]
  3. Respiratory rate (RR) [ Time Frame: Change from baseline at 40 minutes ]
  4. SPO2 [ Time Frame: Change from baseline at 40 minutes ]
    Blood oxygen saturation



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with acute limb trauma, aged 15-65 years, with moderate to severe pain (45 mm; visual analog scale (VAS)), with a GCS score of 15, with the systolic blood pressure of lower than 180 mmHg, diastolic blood pressure of higher than 90 mmHg
  • 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:

  • a decrease in GCS score to less than or equal to 14,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414800


Locations
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Iran, Islamic Republic of
Al-Zahra University Hospital
Isfahan, Iran, Islamic Republic of, 8138938728
Sponsors and Collaborators
Isfahan University of Medical Sciences
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Responsible Party: Mehdi Nasr Isfahani, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04414800    
Other Study ID Numbers: 396828
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It will be possible to share data if requested

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acute Pain
Multiple Trauma
Pain
Neurologic Manifestations
Wounds and Injuries
Fentanyl
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia