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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

Tracking Information
First Submitted Date  ICMJE May 22, 2020
First Posted Date  ICMJE June 4, 2020
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date March 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
Visual analogue score [ Time Frame: Change from baseline at 40 minutes ]
a scale for measuring the extent of pain relief
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • Heart rate (HR) [ Time Frame: Change from baseline at 40 minutes ]
  • Blood pressure (BP) [ Time Frame: Change from baseline at 40 minutes ]
  • Respiratory rate (RR) [ Time Frame: Change from baseline at 40 minutes ]
  • SPO2 [ Time Frame: Change from baseline at 40 minutes ]
    Blood oxygen saturation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Ketamine Versus Intranasal Fentanyl
Official Title  ICMJE Intranasal Ketamine Versus Intranasal Fentanyl on Pain Management in Isolated Traumatic Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Trauma
  • Pain, Acute
Intervention  ICMJE
  • Drug: Placebo
    Distilled water
  • Drug: Ketamine
    1 mg/kg intranasal ketamine
  • Drug: Fentanyl
    1μg/kg intranasal fentanyl
Study Arms  ICMJE
  • Placebo Comparator: Control (Placebo+ Standard of Care))
    Intervention: Drug: Placebo
  • Active Comparator: Ketamine + Standard of Care
    Intervention: Drug: Ketamine
  • Active Comparator: Fentanyl + Standard of Care
    Intervention: Drug: Fentanyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2020)
125
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 15, 2018
Actual Primary Completion Date March 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04414800
Other Study ID Numbers  ICMJE 396828
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: It will be possible to share data if requested
Responsible Party Mehdi Nasr Isfahani, Isfahan University of Medical Sciences
Study Sponsor  ICMJE Isfahan University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Isfahan University of Medical Sciences
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP