Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03421275

Enrollment

105

Registered

2018-02-05

Start date

2017-12-01

Completion date

2022-12-01

Last updated

2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain Due to Trauma

Keywords

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

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.

Interventions

DRUGEsketamine

anesthetic used as analgetic in subanesthetic doses given intranasally

DRUGFentanyl Citrate

intravenous fentanyl given intranasally

DRUGSaline Nasal

intravenous saline given intranasally as placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Finland

Contacts

Primary ContactAnna Meuronen, MD,PhD

anna.meuronen@hus.fi+35819458711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026