Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

NCT03421275 | Unknown Phase 4 FDA Drug

• 1 other identifier: FK_0001
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain Due to Trauma

Keywords

fentanyl; esketamine; ketamine; analgesia; acute pain; minor trauma

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS) change

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

  15 minutes and 30 minutes

Secondary Outcomes (5)

• Amount of patients with NRS change more than -2

  15 min, 30 min, 60 min

• Patient satisfaction (pain management)

  120 min

• Side effects

  120 min

• Amount of study drug consumed (doses)

  120 min

• Need for rescue medication mg (oxycodone)

  120 min

Study Arms (3)

Esketamine

EXPERIMENTAL

intravenous anaesthetic and analgetic

Drug: Esketamine

Fentanyl Citrate

ACTIVE COMPARATOR

intravenous opioid analgetic

Drug: Fentanyl Citrate

Saline Nasal

PLACEBO COMPARATOR

intravenous "Natriumklorid b. Braun 9 mg/ml"

Drug: Saline Nasal

Interventions

Esketamine DRUG

anesthetic used as analgetic in subanesthetic doses given intranasally

Also known as: Ketanest-S

Esketamine

Fentanyl Citrate DRUG

intravenous fentanyl given intranasally

Also known as: Fentanyl-Hameln

Fentanyl Citrate

Saline Nasal DRUG

intravenous saline given intranasally as placebo

Also known as: Natriumklorid b. Braun 9 mg/ml

Saline Nasal

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Anna Meuronen, MD: lead

Study Sites (1)

Hyvinkää Hospital

Hyvinkää, Finland

RECRUITING

MeSH Terms

Conditions

Agnosia; Acute Pain

Interventions

Esketamine; Fentanyl; Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Anna Meuronen, MD,PhD

  consultant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Meuronen, MD,PhD

CONTACT

+35819458711; anna.meuronen@hus.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 5, 2018
• Study Start: December 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)