Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

Anna Meuronen, MD

Status and phase: Unknown; Phase 4

Conditions: Acute Pain Due to Trauma

Treatments: Drug: Esketamine; Drug: Saline Nasal; Drug: Fentanyl Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03421275

FK_0001

Details and patient eligibility

About

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups, including a placebo group

Esketamine

Experimental group

Description:

intravenous anaesthetic and analgetic

Treatment:

Drug: Esketamine

Fentanyl Citrate

Active Comparator group

Description:

intravenous opioid analgetic

Treatment:

Drug: Fentanyl Citrate

Saline Nasal

Placebo Comparator group

Description:

intravenous "Natriumklorid b. Braun 9 mg/ml"

Treatment:

Drug: Saline Nasal