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Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03421275
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Anna Meuronen, MD, Hospital District of Helsinki and Uusimaa

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Pain Due to Trauma Drug: Esketamine Drug: Fentanyl Citrate Drug: Saline Nasal Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intranasal Fentanyl and Esketamine for Treatment of Acute Pain in Minor Trauma Patients
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Esketamine
intravenous anaesthetic and analgetic
 Drug: Esketamine
anesthetic used as analgetic in subanesthetic doses given intranasally
Other Name: Ketanest-S
Active Comparator: Fentanyl Citrate
intravenous opioid analgetic
 Drug: Fentanyl Citrate
intravenous fentanyl given intranasally
Other Name: Fentanyl-Hameln
Placebo Comparator: Saline Nasal
intravenous "Natriumklorid b. Braun 9 mg/ml"
 Drug: Saline Nasal
intravenous saline given intranasally as placebo
Other Name: Natriumklorid b. Braun 9 mg/ml


Outcome Measures
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Primary Outcome Measures :
  1. Numeric rating scale (NRS) change [ Time Frame: 15 minutes and 30 minutes ]
    Numeric rating scale is used to measure pain intensity. Scale is from 0-10. 0 = no pain, 10 = worst imegeable


Secondary Outcome Measures :
  1. Amount of patients with NRS change more than -2 [ Time Frame: 15 min, 30 min, 60 min ]
    Amount of patients with NRS dropping more than 2 at time poin 15 minutes, 20 minutes and 60 minutes

  2. Patient satisfaction (pain management) [ Time Frame: 120 min ]
    Whole experience of pain management on NRS scale from 0-10 (0 = absolutely terrible, 10 = best imagenable)

  3. Side effects [ Time Frame: 120 min ]
  4. Amount of study drug consumed (doses) [ Time Frame: 120 min ]
    Amount of sturdy drug consumed as doses in the end of study period. One dose is determined by patient weight.

  5. Need for rescue medication mg (oxycodone) [ Time Frame: 120 min ]
    Amount of oral or intramuscular oxycodone consumption in the end of study period as milligrams


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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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): NCT03421275


Contacts
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Contact: Anna Meuronen, MD,PhD +35819458711 anna.meuronen@hus.fi

Locations
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Finland
Hyvinkää Hospital Recruiting
Hyvinkää, Finland
Contact: Anna Meuronen, MD, PhD       anna.meuronen@hus.fi   
Sponsors and Collaborators
Anna Meuronen, MD
Investigators
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Principal Investigator: Anna Meuronen, MD,PhD consultant
More Information
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Responsible Party: Anna Meuronen, MD, Principal Investigator, Hospital District of Helsinki and Uusimaa
ClinicalTrials.gov Identifier: NCT03421275    
Other Study ID Numbers: FK_0001
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Anna Meuronen, MD, Hospital District of Helsinki and Uusimaa:
fentanyl
esketamine
ketamine
 analgesia
acute pain
minor trauma
Additional relevant MeSH terms:
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Acute Pain
Wounds and Injuries
Pain
Neurologic Manifestations
Fentanyl
Esketamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antidepressive Agents
Psychotropic Drugs