Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

February 11, 2020 updated by: Anna Meuronen, MD

Intranasal Fentanyl and Esketamine for Treatment of Acute Pain in Minor Trauma Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Esketamine
intravenous anaesthetic and analgetic
Drug: Esketamine
anesthetic used as analgetic in subanesthetic doses given intranasally
Other Names:
  • Ketanest-S
ACTIVE_COMPARATOR: Fentanyl Citrate
intravenous opioid analgetic
Drug: Fentanyl Citrate
intravenous fentanyl given intranasally
Other Names:
  • Fentanyl-Hameln
PLACEBO_COMPARATOR: Saline Nasal
intravenous "Natriumklorid b. Braun 9 mg/ml"
Drug: Saline Nasal
intravenous saline given intranasally as placebo
Other Names:
  • Natriumklorid b. Braun 9 mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 minutes and 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 min, 30 min, 60 min
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)
120 min
Side effects
Time Frame: 120 min
120 min
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.
120 min
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
120 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Meuronen, MD

Investigators

  • Principal Investigator: Anna Meuronen, MD,PhD, Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

January 29, 2018

First Posted (ACTUAL)

February 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FK_0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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