PainPhase 3NCT07305883
Comparison of Intranasal Ketorolac and Intranasal Ketamine in Digital Nerve Block Pain
A Phase 3 study testing Intranasal Ketorolac Tromethamine and Intranasal ketamine in people with Pain and Digital Block, run by Tehran University of Medical Sciences.
Trial summary
This study aims to compare the analgesic effectiveness and side effects of intranasal ketorolac versus intranasal ketamine for reducing pain prior to digital nerve block procedures in patients with finger injuries in emergency department. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Digital Block
- What is being tested?
- Intranasal Ketorolac Tromethamine and Intranasal ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 28 Dec 2025to 1 Aug 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years
- Weight > 50 kg
- Requires digital nerve block
- Able to provide informed consent
Who cannot join
- Active peptic ulcer disease (PUD)
- History of hypersensitivity to NSAIDs
- Pregnancy and breastfeeding
- Renal failure
- Hepatic failure
- Patients who have received analgesics within the past 6 hours
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- Nasal congestion
- Upper respiratory tract infection
- Patients with a history of kidney transplantation
- Active gastrointestinal bleeding
- Systolic blood pressure less than 90 mmHg or greater than 180 mmHg
- Heart rate less than 50 per minute or greater than 150 per minute
- Concurrent use of NSAIDs or anticoagulant drugs
- Inability to provide informed consent
- Anatomical abnormalities of the nose or skull base (congenital or acquired)
- Hyperreactive airway disease such as severe asthma
- Coagulation disorders
- Intracranial hemorrhage
- Suspected aortic dissection
- Suspected rupture of abdominal aortic aneurysm
- History of gastrointestinal perforation
- Gastrointestinal bleeding within the past month
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intranasal Ketorolac Effectiveness In Comparison To Intranasal Ketamine for Digital Nerve Block Pain; A Randomized, Double Blind Trial
This study aims to compare the analgesic effectiveness and side effects of intranasal ketorolac versus intranasal ketamine for reducing pain prior to digital nerve block procedures in patients with finger injuries in emergency department.
Read the detailed description
Acute pain management in emergency department during painful procedures such as digital nerve block is crucial to be implemented in a rapid-onset method. Ketorolac, a potent NSAID, and ketamine, an NMDA receptor antagonist with analgesic effects, have both been shown to be effective and fast-onset when administered intranasally. This non-invasive method of Ketorolac is not supported by sufficient evidences in such clinical scenarios. Addressing this research gap may lead to reduced pain and complications, as well as higher patient satisfaction, contributing the development of novel pre-procedural analgesic strategies in emergency settings.
Participants will be randomly assigned to receive either 30 mg intranasal ketorolac or 50 mg intranasal ketamine, administered 5 minutes prior to the digital nerve block. Pain will be assessed using the Numeric Rating Scale (NRS). Secondary endpoints include nasal irritation, side effects, and patient satisfaction.
- Conditions
- Pain, Digital Block
- Being tested
- Intranasal Ketorolac Tromethamine, Intranasal ketamine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Ketorolac TromethamineDrug
30 mg ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril, Given 5 minutes before digital nerve block.
Intranasal ketamineDrug
50 mg ketamine will be administered intranasally using mucosal atomizer,. Half dose (0.5cc) in each nostril, Given 5 minutes before digital nerve block
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Ketamine | Active comparator | 50 mg ketamine will be administered intranasally using mucosal atomizer,. Half dose (0.5cc) in each nostril, Given 5 minutes before digital nerve block Receives: Drug: Intranasal ketamine |
| Intranasal Ketorolac Tromethamine | Experimental | 30 mg ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril, Given 5 minutes before digital nerve block. Receives: Drug: Intranasal Ketorolac Tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block pain intensity
The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity. The pain severity will be asked from the patients.
Measured: Immediately after block
Secondary outcomes (3)
Nasal irritation
We will ask the patients about this outcome use a 3-level Likert-like scale.
Measured: 60 minutes after the block
Side effects
The patients will be assessed every 15 minutes for this outcome.
Measured: From the drug administration to 60 minutes after the block
Patient satisfaction score
The patients will be asked about their satisfaction using a 3-level Likert like scale.
Measured: 60 minutes after the drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start28 Dec 2025 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hadi Mirfazaelian, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305883
- Sponsor's protocol ID
- 1404-5-243-91681
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information is not allowed to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Ketorolac Effectiveness In Comparison To Intranasal Ketamine for Digital Nerve Block Pain; A Randomized, Double Blind Trial
- ClinicalTrials.gov ID
- NCT07305883
- Acronym / sponsor ID
- 1404-5-243-91681
- Conditions
- Pain, Digital Block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 28 Dec 2025 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 26 Dec 2025 (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.
This study aims to compare the analgesic effectiveness and side effects of intranasal ketorolac versus intranasal ketamine for reducing pain prior to digital nerve block procedures in patients with finger injuries in emergency department.
Detailed description
Acute pain management in emergency department during painful procedures such as digital nerve block is crucial to be implemented in a rapid-onset method. Ketorolac, a potent NSAID, and ketamine, an NMDA receptor antagonist with analgesic effects, have both been shown to be effective and fast-onset when administered intranasally. This non-invasive method of Ketorolac is not supported by sufficient evidences in such clinical scenarios. Addressing this research gap may lead to reduced pain and complications, as well as higher patient satisfaction, contributing the development of novel pre-procedural analgesic strategies in emergency settings.
Participants will be randomly assigned to receive either 30 mg intranasal ketorolac or 50 mg intranasal ketamine, administered 5 minutes prior to the digital nerve block. Pain will be assessed using the Numeric Rating Scale (NRS). Secondary endpoints include nasal irritation, side effects, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Ketamine | Active comparator | Drug: Intranasal ketamine50 mg ketamine will be administered intranasally using mucosal atomizer,. Half dose (0.5cc) in each nostril, Given 5 minutes before digital nerve block |
| Intranasal Ketorolac Tromethamine | Experimental | Drug: Intranasal Ketorolac Tromethamine30 mg ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril, Given 5 minutes before digital nerve block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18-65 years
- Weight > 50 kg
- Requires digital nerve block
- Able to provide informed consent
Key exclusion criteria (22 listed)
- Active peptic ulcer disease (PUD)
- History of hypersensitivity to NSAIDs
- Pregnancy and breastfeeding
- Renal failure
- Hepatic failure
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 |
|---|---|---|
| Intranasal Ketorolac Tromethamine30 mg ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril, Given 5 minutes before digital nerve block. | Drug | Intranasal Ketorolac Tromethamine |
| Intranasal ketamine50 mg ketamine will be administered intranasally using mucosal atomizer,. Half dose (0.5cc) in each nostril, Given 5 minutes before digital nerve block | Drug | Intranasal Ketamine |
Primary outcome
Block pain intensity
Time frame: Immediately after block
The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity. The pain severity will be asked from the patients.
3 secondary outcomes
Nasal irritation
Time frame: 60 minutes after the block
Side effects
Time frame: From the drug administration to 60 minutes after the block
Patient satisfaction score
Time frame: 60 minutes after the drug administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No. The information is not allowed to be shared.
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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.
Hadi Mirfazaelian principal investigator
Tehran University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intranasal Ketorolac Tromethamine and Intranasal ketamine in people with Pain and Digital Block, run by Tehran University of Medical Sciences.
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 4 inclusion and 22 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: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hadi Mirfazaelian, MD (00982161192240, h-mirfazaelian@sina.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block pain intensity (time frame: Immediately after block). 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 26 Dec 2025.