Status:

UNKNOWN

Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

Lead Sponsor:

Anna Meuronen, MD

Conditions:

Acute Pain Due to Trauma

Eligibility:

All Genders

18-80 years

Phase:

PHASE4

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.

Eligibility Criteria

Inclusion

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

Exclusion

  • 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)

Key Trial Info

Start Date :

December 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2022

Estimated Enrollment :

105 Patients enrolled

Trial Details

Trial ID

NCT03421275

Start Date

December 1 2017

End Date

December 1 2022

Last Update

February 13 2020

Active Locations (1)

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1

Hyvinkää Hospital

Hyvinkää, Finland