Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

Ketamine

Brief Summary

Intranasal esketamine, fentanyl and placebo are compared in treatment of acute pain in adult patients with minor trauma. Study is blinded randomized placebo-controlled parallel design.

Intervention / Treatment

  • Esketamine (DRUG)
    anesthetic used as analgetic in subanesthetic doses given intranasally
  • Fentanyl Citrate (DRUG)
    intravenous fentanyl given intranasally
  • Saline Nasal (DRUG)
    intravenous saline given intranasally as placebo

Condition or Disease

  • Acute Pain Due to Trauma

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 80 Years
    Enrollment: 105 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Dec 01, 2017 ACTUAL
    Primary Completion: Dec 01, 2022 ESTIMATED
    Completion Date: Dec 01, 2022 ESTIMATED
    Study First Posted: Feb 05, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Feb 11, 2020

    Sponsors / Collaborators

    Lead Sponsor: Anna Meuronen, MD
    Responsible Party: Anna Meuronen, MD

    Location

    Hyvinkää, Uusimaa, Finland

    Participant Groups

    • intravenous anaesthetic and analgetic

    • intravenous opioid analgetic

    • intravenous "Natriumklorid b. Braun 9 mg/ml"

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 80
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * NRS 5 or more, minor trauma, no need for immediate iv cannulation, weight 45-115 kg

    Exclusion Criteria:

    * pregnancy, breastfeeding, head trauma, severe chronic obstructive pulmonary disease (COPD), gfr under 30, liver cirrhosis, mental illness other than mild/moderate depression, sleep apnea, unstable coronary artery disease (CAD), unstable heart failure (HF), intoxication, untreated hypertension, dementia, do not understand Finnish, contraindication to nasal spray, allergy to any of the medications, bradycardia, desaturation, suspected high intracranial pressure (ICP)

    Primary Outcomes

    • Numeric rating scale is used to measure pain intensity. Scale is from 0-10. 0 = no pain, 10 = worst imegeable

    Secondary Outcomes

    • Amount of patients with NRS dropping more than 2 at time poin 15 minutes, 20 minutes and 60 minutes

    • Whole experience of pain management on NRS scale from 0-10 (0 = absolutely terrible, 10 = best imagenable)

    • Side effects 120 min

    • Amount of sturdy drug consumed as doses in the end of study period. One dose is determined by patient weight.

    • Amount of oral or intramuscular oxycodone consumption in the end of study period as milligrams

    More Details

    NCT Number: NCT03421275
    Other IDs: FK_0001
    Study URL: https://clinicaltrials.gov/study/NCT03421275
    Last updated: Sep 29, 2023