Intranasal Esketamine and Fentanyl for Pain in Minor Trauma

Phase 4

• Conditions: Acute Pain Due to Trauma
• Interventions: Drug: Fentanyl Citrate; Drug: Saline Nasal; Drug: Esketamine

• Registration Number: NCT03421275
• Lead Sponsor: Anna Meuronen, MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-02-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl Citrate	Fentanyl Citrate	intravenous opioid analgetic
Saline Nasal	Saline Nasal	intravenous "Natriumklorid b. Braun 9 mg/ml"
Esketamine	Esketamine	intravenous anaesthetic and analgetic

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Need for rescue medication mg (oxycodone)	120 min	Amount of oral or intramuscular oxycodone consumption in the end of study period as milligrams
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.

Trial Locations

Locations (1)

Hyvinkää Hospital; 🇫🇮 Hyvinkää, Finland