Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

Sponsor

Anna Meuronen, MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT03421275

Collaborator

(none)

105

Enrollment

Location

Arms

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain Due to Trauma	Drug: Esketamine Drug: Fentanyl Citrate Drug: Saline Nasal	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Numeric rating scale (NRS) change [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

Secondary Outcome Measures

Amount of patients with NRS change more than -2 [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
Patient satisfaction (pain management) [120 min]
Whole experience of pain management on NRS scale from 0-10 (0 = absolutely terrible, 10 = best imagenable)
Side effects [120 min]
Amount of study drug consumed (doses) [120 min]
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) [120 min]
Amount of oral or intramuscular oxycodone consumption in the end of study period as milligrams

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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)