Multiple TraumaPhase 3NCT04414800
Intranasal Ketamine Versus Intranasal Fentanyl
A Phase 3 study testing Ketamine and Fentanyl in people with Multiple Trauma and Pain, Acute, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Abstract Background: Given the inadequate control of pain in patients with injury that refer to the emergency departments, the rapid onset of action of intranasal administration in pain management, and the avoidance of administering opioid medications, the present study aimed at evaluating the effect of intranasal… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Multiple Trauma, Pain, Acute
- What is being tested?
- Ketamine and Fentanyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteIran
- Study dates
- 1 Apr 2017to 15 Apr 2018
- Phase
- Phase 3
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with acute limb trauma, aged 15-65 years, with moderate to severe pain (45 mm; visual analog scale (VAS)), with a GCS score of 15, with the systolic blood pressure of lower than 180 mmHg, diastolic blood pressure of higher than 90 mmHg
- lack of pregnancy
- no history of allergy to ketamine, fentanyl (or opioids), or acetaminophen,
- no history of liver diseases,
- no acute or chronic structural or functional nasal obstruction diseases,
- no history of drug or psychiatric addiction,
Show all 9Show fewer
- no pain medication within the past four hours,
- no history of heart disease,
- and the presentation of the written consent to participate in the study.
Who cannot join
- a decrease in GCS score to less than or equal to 14,
- an elevated systolic blood pressure to higher than 180 mmHg,
- a decreased diastolic blood pressure to less than 80 mmHg,
- inability to understand the VAS pain rating system,
- symptoms of acute heart disease and respiratory depression (respiratory rate <8 / min),
- and the patient's dissatisfaction to continue the cooperation in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intranasal Ketamine Versus Intranasal Fentanyl on Pain Management in Isolated Traumatic Patients
Abstract Background: Given the inadequate control of pain in patients with injury that refer to the emergency departments, the rapid onset of action of intranasal administration in pain management, and the avoidance of administering opioid medications, the present study aimed at evaluating the effect of intranasal ketamine versus intranasal fentanyl on pain management in isolated traumatic patients Materials and Methods: The current study was performed on 125 patients that were divided into the following three groups: control group (n = 41), 1 mg/kg intranasal ketamine group (n = 40), and 1μg/kg intranasal fentanyl group (n = 44). Then pain scores, HR, RR, BP, and SaO2 were recorded at baseline, 5, 10, 15, 30, and 40 minutes after the intervention.
- Conditions
- Multiple Trauma, Pain, Acute
- Medical subject headings
- Multiple Trauma, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Distilled water
KetamineDrug
1 mg/kg intranasal ketamine
FentanylDrug
1μg/kg intranasal fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Control (Placebo+ Standard of Care)) | Placebo comparator | Not described Receives: Drug: Placebo |
| Ketamine + Standard of Care | Active comparator | Not described Receives: Drug: Ketamine |
| Fentanyl + Standard of Care | Active comparator | Not described Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score
a scale for measuring the extent of pain relief
Measured: Change from baseline at 40 minutes
Secondary outcomes (4)
Heart rate (HR)
Measured: Change from baseline at 40 minutes
Blood pressure (BP)
Measured: Change from baseline at 40 minutes
Respiratory rate (RR)
Measured: Change from baseline at 40 minutes
SPO2
Blood oxygen saturation
Measured: Change from baseline at 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Apr 2017
- Primary completion20 Mar 2018
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Nasr Isfahani, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414800
- Sponsor's protocol ID
- 396828
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be possible to share data if requested
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Ketamine Versus Intranasal Fentanyl on Pain Management in Isolated Traumatic Patients
- ClinicalTrials.gov ID
- NCT04414800
- Acronym / sponsor ID
- 396828
- Conditions
- Multiple Trauma, Pain, Acute
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 4 Jun 2020 (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.
Abstract Background: Given the inadequate control of pain in patients with injury that refer to the emergency departments, the rapid onset of action of intranasal administration in pain management, and the avoidance of administering opioid medications, the present study aimed at evaluating the effect of intranasal ketamine versus intranasal fentanyl on pain management in isolated traumatic patients Materials and Methods: The current study was performed on 125 patients that were divided into the following three groups: control group (n = 41), 1 mg/kg intranasal ketamine group (n = 40), and 1μg/kg intranasal fentanyl group (n = 44). Then pain scores, HR, RR, BP, and SaO2 were recorded at baseline, 5, 10, 15, 30, and 40 minutes after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (Placebo+ Standard of Care)) | Placebo comparator | Drug: Placebo |
| Ketamine + Standard of Care | Active comparator | Drug: Ketamine |
| Fentanyl + Standard of Care | Active comparator | Drug: Fentanyl |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- patients with acute limb trauma, aged 15-65 years, with moderate to severe pain (45 mm; visual analog scale (VAS)), with a GCS score of 15, with the systolic blood pressure of lower than 180 mmHg, diastolic blood pressure of higher than 90 mmHg
- lack of pregnancy
- no history of allergy to ketamine, fentanyl (or opioids), or acetaminophen,
- no history of liver diseases,
- no acute or chronic structural or functional nasal obstruction diseases,
Key exclusion criteria (6 listed)
- a decrease in GCS score to less than or equal to 14,
- an elevated systolic blood pressure to higher than 180 mmHg,
- a decreased diastolic blood pressure to less than 80 mmHg,
- inability to understand the VAS pain rating system,
- symptoms of acute heart disease and respiratory depression (respiratory rate <8 / min),
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 |
|---|---|---|
| PlaceboDistilled water | Drug | Control (Placebo+ Standard of Care)) |
| Ketamine1 mg/kg intranasal ketamine | Drug | Ketamine + Standard of Care |
| Fentanyl1μg/kg intranasal fentanyl | Drug | Fentanyl + Standard of Care |
Primary outcome
Visual analogue score
Time frame: Change from baseline at 40 minutes
a scale for measuring the extent of pain relief
4 secondary outcomes
Heart rate (HR)
Time frame: Change from baseline at 40 minutes
Blood pressure (BP)
Time frame: Change from baseline at 40 minutes
Respiratory rate (RR)
Time frame: Change from baseline at 40 minutes
SPO2
Time frame: Change from baseline at 40 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No. It will be possible to share data if requested
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine and Fentanyl in people with Multiple Trauma and Pain, Acute, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 9 inclusion and 6 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: finished, as of the sponsor's last update on 4 Jun 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 Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue score (time frame: Change from baseline at 40 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 4 Jun 2020; AzTrials last refreshed its copy on 4 Nov 2026.