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Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

Primary Purpose

Acute Pain Due to Trauma

Status

Unknown status

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

Esketamine

Fentanyl Citrate

Saline Nasal

About this trial

This is an interventional treatment trial for Acute Pain Due to Trauma focused on measuring fentanyl, esketamine, ketamine, analgesia, acute pain, minor trauma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Hyvinkää HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Esketamine

Fentanyl Citrate

Saline Nasal

Arm Description

intravenous anaesthetic and analgetic

intravenous opioid analgetic

intravenous "Natriumklorid b. Braun 9 mg/ml"

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Amount of patients with NRS change more than -2

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

Patient satisfaction (pain management)

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

Side effects

Amount of study drug consumed (doses)

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

Need for rescue medication mg (oxycodone)

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

Full Information

NCT ID

NCT03421275

First Posted

January 18, 2018

Last Updated

February 11, 2020

Sponsor

Anna Meuronen, MD

1. Study Identification

Unique Protocol Identification Number

NCT03421275

Brief Title

Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Anna Meuronen, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pain Due to Trauma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Esketamine

Arm Type

Experimental

Arm Description

intravenous anaesthetic and analgetic

Arm Title

Fentanyl Citrate

Arm Type

Active Comparator

Arm Description

intravenous opioid analgetic

Arm Title

Saline Nasal

Arm Type

Placebo Comparator

Arm Description

intravenous "Natriumklorid b. Braun 9 mg/ml"

Intervention Type

Drug

Intervention Name(s)

Esketamine

Other Intervention Name(s)

Ketanest-S

Intervention Description

anesthetic used as analgetic in subanesthetic doses given intranasally

Intervention Type

Drug

Intervention Name(s)

Fentanyl Citrate

Other Intervention Name(s)

Fentanyl-Hameln

Intervention Description

intravenous fentanyl given intranasally

Intervention Type

Drug

Intervention Name(s)

Saline Nasal

Other Intervention Name(s)

Natriumklorid b. Braun 9 mg/ml

Intervention Description

intravenous saline given intranasally as placebo

Primary Outcome Measure Information:

Title

Numeric rating scale (NRS) change

Description

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

Time Frame

15 minutes and 30 minutes

Secondary Outcome Measure Information:

Title

Amount of patients with NRS change more than -2

Description

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

Time Frame

15 min, 30 min, 60 min

Title

Patient satisfaction (pain management)

Description

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

Time Frame

120 min

Title

Side effects

Time Frame

120 min

Title

Amount of study drug consumed (doses)

Description

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

Time Frame

120 min

Title

Need for rescue medication mg (oxycodone)

Description

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

Time Frame

120 min

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Meuronen, MD,PhD

Phone

+35819458711

anna.meuronen@hus.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Meuronen, MD,PhD

Organizational Affiliation

consultant

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hyvinkää Hospital

City

Hyvinkää

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Meuronen, MD, PhD

anna.meuronen@hus.fi

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

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