Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Pain Due to Trauma

Intervention / Treatment
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* Drug: Esketamine
* Drug: Fentanyl Citrate
* Drug: Saline Nasal


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esketamine<br>intravenous anaesthetic and analgetic | Drug: Esketamine<br>* anesthetic used as analgetic in subanesthetic doses given intranasally<br>* Other names: Ketanest-S;|
| Active Comparator: Fentanyl Citrate<br>intravenous opioid analgetic | Drug: Fentanyl Citrate<br>* intravenous fentanyl given intranasally<br>* Other names: Fentanyl-Hameln;|
| Placebo Comparator: Saline Nasal<br>intravenous Natriumklorid b. Braun 9 mg/ml | Drug: Saline Nasal<br>* intravenous saline given intranasally as placebo<br>* Other names: Natriumklorid b. Braun 9 mg/ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Patient satisfaction (pain management) | Whole experience of pain management on NRS scale from 0-10 (0 = absolutely terrible, 10 = best imagenable) | 120 min | 
| Side effects |  | 120 min | 
| 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 | 
| Need for rescue medication mg (oxycodone) | Amount of oral or intramuscular oxycodone consumption in the end of study period as milligrams | 120 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fentanyl, esketamine, ketamine, analgesia, acute pain, minor trauma