Acute Pain Due to TraumaPhase 4NCT03421275
Intranasal Esketamine and Fentanyl for Pain in Minor Trauma
A Phase 4 study testing Esketamine, Fentanyl Citrate and Saline Nasal in people with Acute Pain Due to Trauma, run by Anna Meuronen, MD at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pain Due to Trauma
- What is being tested?
- Esketamine, Fentanyl Citrate and Saline Nasal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteFinland
- Study dates
- 1 Dec 2017to 1 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NRS 5 or more, minor trauma, no need for immediate iv cannulation, weight 45-115 kg
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Hyvinkää Hospital
Hyvinkää
Anna Meuronen, MD, PhD, anna.meuronen@hus.fi
About this study
Official title: Intranasal Fentanyl and Esketamine for Treatment of Acute Pain in Minor Trauma Patients
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.
- Conditions
- Acute Pain Due to Trauma
- Being tested
- Esketamine, Fentanyl Citrate, Saline Nasal
- Keywords
- fentanyl, esketamine, ketamine, analgesia, acute pain, minor trauma
- Medical subject headings
- Agnosia, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Also called Ketanest-S
anesthetic used as analgetic in subanesthetic doses given intranasally
Fentanyl CitrateDrug
Also called Fentanyl-Hameln
intravenous fentanyl given intranasally
Saline NasalDrug
Also called Natriumklorid b. Braun 9 mg/ml
intravenous saline given intranasally as placebo
| Study group | Role | What they receive |
|---|---|---|
| Esketamine | Experimental | intravenous anaesthetic and analgetic Receives: Drug: Esketamine |
| Fentanyl Citrate | Active comparator | intravenous opioid analgetic Receives: Drug: Fentanyl Citrate |
| Saline Nasal | Placebo comparator | intravenous "Natriumklorid b. Braun 9 mg/ml" Receives: Drug: Saline Nasal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS) change
Numeric rating scale is used to measure pain intensity. Scale is from 0-10. 0 = no pain, 10 = worst imegeable
Measured: 15 minutes and 30 minutes
Secondary outcomes (5)
Amount of patients with NRS change more than -2
Amount of patients with NRS dropping more than 2 at time poin 15 minutes, 20 minutes and 60 minutes
Measured: 15 min, 30 min, 60 min
Patient satisfaction (pain management)
Whole experience of pain management on NRS scale from 0-10 (0 = absolutely terrible, 10 = best imagenable)
Measured: 120 min
Side effects
Measured: 120 min
Amount of study drug consumed (doses)
Amount of sturdy drug consumed as doses in the end of study period. One dose is determined by patient weight.
Measured: 120 min
Need for rescue medication mg (oxycodone)
Amount of oral or intramuscular oxycodone consumption in the end of study period as milligrams
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Dec 2017
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pain Due to TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Meuronen, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Meuronen, MD, Hospital District of Helsinki and Uusimaa
- Investigators
- Anna Meuronen, MD,PhD, Principal investigator, consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421275
- Sponsor's protocol ID
- FK_0001
- Status last verified
- Feb 2020
- First submitted
- 18 Jan 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Fentanyl and Esketamine for Treatment of Acute Pain in Minor Trauma Patients
- ClinicalTrials.gov ID
- NCT03421275
- Acronym / sponsor ID
- FK_0001
- Conditions
- Acute Pain Due to Trauma
- Keywords
- fentanyl, esketamine, ketamine, analgesia, acute pain, minor trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Anna Meuronen, MDUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Esketamine | Experimental | Drug: Esketamineintravenous anaesthetic and analgetic |
| Fentanyl Citrate | Active comparator | Drug: Fentanyl Citrateintravenous opioid analgetic |
| Saline Nasal | Placebo comparator | Drug: Saline Nasalintravenous "Natriumklorid b. Braun 9 mg/ml" |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- NRS 5 or more, minor trauma, no need for immediate iv cannulation, weight 45-115 kg
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineAlso: Ketanest-Sanesthetic used as analgetic in subanesthetic doses given intranasally | Drug | Esketamine |
| Fentanyl CitrateAlso: Fentanyl-Hamelnintravenous fentanyl given intranasally | Drug | Fentanyl Citrate |
| Saline NasalAlso: Natriumklorid b. Braun 9 mg/mlintravenous saline given intranasally as placebo | Drug | Saline Nasal |
Primary outcome
Numeric rating scale (NRS) change
Time frame: 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
5 secondary outcomes
Amount of patients with NRS change more than -2
Time frame: 15 min, 30 min, 60 min
Patient satisfaction (pain management)
Time frame: 120 min
Side effects
Time frame: 120 min
Amount of study drug consumed (doses)
Time frame: 120 min
Need for rescue medication mg (oxycodone)
Time frame: 120 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Meuronen, MD,PhD principal investigator
consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esketamine, Fentanyl Citrate and Saline Nasal in people with Acute Pain Due to Trauma, run by Anna Meuronen, MD at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Meuronen, MD,PhD (+35819458711, anna.meuronen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) change (time frame: 15 minutes and 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.