Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

Acute Pain Due to Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03421275
• Other study ID #: FK_0001
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2020
• Source: Hospital District of Helsinki and Uusimaa
• Contact: Anna Meuronen, MD,PhD
• Phone: +35819458711
• Email: anna.meuronen[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Due to Trauma
• Wounds and Injuries

Intervention

Drug:
• Esketamine
anesthetic used as analgetic in subanesthetic doses given intranasally
• Fentanyl Citrate
intravenous fentanyl given intranasally
• Saline Nasal
intravenous saline given intranasally as placebo

Locations

Country	Name	City	State
Finland	Hyvinkää Hospital	Hyvinkää

Sponsors (1)

Lead Sponsor	Collaborator
Anna Meuronen, MD

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	15 min, 30 min, 60 min
Secondary	Patient satisfaction (pain management)	Whole experience of pain management on NRS scale from 0-10 (0 = absolutely terrible, 10 = best imagenable)	120 min
Secondary	Side effects		120 min
Secondary	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.	120 min
Secondary	Need for rescue medication mg (oxycodone)	Amount of oral or intramuscular oxycodone consumption in the end of study period as milligrams	120 min