Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2022-12-01

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.

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Detailed Description

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Conditions

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Acute Pain Due to Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Esketamine

intravenous anaesthetic and analgetic

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

anesthetic used as analgetic in subanesthetic doses given intranasally

Fentanyl Citrate

intravenous opioid analgetic

Group Type ACTIVE_COMPARATOR

Fentanyl Citrate

Intervention Type DRUG

intravenous fentanyl given intranasally

Saline Nasal

intravenous "Natriumklorid b. Braun 9 mg/ml"

Group Type PLACEBO_COMPARATOR

Saline Nasal

Intervention Type DRUG

intravenous saline given intranasally as placebo

Interventions

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Esketamine

anesthetic used as analgetic in subanesthetic doses given intranasally

Intervention Type DRUG

Fentanyl Citrate

intravenous fentanyl given intranasally

Intervention Type DRUG

Saline Nasal

intravenous saline given intranasally as placebo

Intervention Type DRUG

Other Intervention Names

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Ketanest-S Fentanyl-Hameln Natriumklorid b. Braun 9 mg/ml

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No