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PainPhase 3NCT07816302

Atomized Intranasal Ketorolac at 30 mg Versus 20 mg for the Treatment of Acute Pain in the Emergency Department

A Phase 3 study testing 20mg intranasal ketorolac and 30mg Intranasal Ketorolac in people with Pain and Ketorolac, run by Tehran University of Medical Sciences.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to compare the analgesic effectiveness and side effects of intranasal ketorolac at 30 mg Versus 20 mg for the Treatment of Acute moderate and severe Pain in the Emergency Department. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pain, Ketorolac, Intranasal Drug Administration
What is being tested?
20mg intranasal ketorolac and 30mg Intranasal Ketorolac
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
10 Oct 2026to 1 May 2027
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
  • Able to provide informed consent
  • Acute pain (<48 hours) with verbally administered NRS≥4 (0-10 range, 0 = no - pain and 10 = worst imaginable pain)

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
Show all 27Show fewer
  • 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
  • Chronic pain disorders
  • Substance misuse
  • Immediate opioid necessity
  • Altered mental status
  • Any pain that is considered to be not appropriate for receiving NSAIDS by emergency physician

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hadi Mirfazaelian, MD contact

00982161192240

h-mirfazaelian@sina.tums.ac.ir

About this study

Official title: Atomized Intranasal Ketorolac at 30 mg Versus 20 mg for the Treatment of Acute Pain in the Emergency Department: A Randomized Non-inferiority Trial

This study aims to compare the analgesic effectiveness and side effects of intranasal ketorolac at 30 mg Versus 20 mg for the Treatment of Acute moderate and severe Pain in the Emergency Department.

Read the detailed description

Pain control is one of the problems in emergency departments (EDs). Analgesics in the intranasal (IN) form have been come into interest and focus because of their ease of application and effectiveness. Recently, IN ketorolac at 30mg has been turned out to have comparable efficacy with parenteral forms. Considering the ceiling effect of the ketorolac, this trial will study whether lower dose of 20mg for pain management is equally effective as 30mg dose.

The study is a multicenter, prospective, randomized, double blind, parallel group non inferiority clinical trial conducted in three EDs. Eligible participants are adults aged 18-65 years presenting with acute moderate to severe pain [numeric rating scale (NRS)≥4]. Participants will be randomized to receive atomized IN ketorolac 20 mg or 30 mg. Primary outcome is change in pain reduction at 30 minutes post administration. Secondary outcomes include pain reduction at 15, 45, and 60 minutes, requirement for rescue analgesia (IV morphine 0.1 mg/kg available at 30), gastrointestinal and other adverse effects, and patient satisfaction.

Being tested
20mg intranasal ketorolac, 30mg Intranasal Ketorolac
Keywords
Emergency department, pain, intranasal, ceiling effect, Ketorolac
Medical subject headings
Pain, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 20mg intranasal ketorolacDrug

    20 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril

  • 30mg Intranasal KetorolacDrug

    30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril

Study groups in NCT07816302
Study groupRoleWhat they receive
30mg Intranasal KetorolacActive comparator30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril
Receives: Drug: 30mg Intranasal Ketorolac
20mg intranasal ketorolacExperimental30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril.
Receives: Drug: 20mg intranasal ketorolac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score at 30 minutes

    Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)

    Measured: 30 minutes post-administration

Secondary outcomes (7)

  1. Pain score at 15 minutes

    Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)

    Measured: 15 minutes post-administration

  2. Pain score at 45 minutes

    Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)

    Measured: 45 minutes post-administration

  3. Pain score at 60 minutes

    Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)

    Measured: 60 minutes post-administration

  4. Need for rescue analgesia

    IV morphine 0.1 mg/kg will be available at 30 minutes in cases of patients request

    Measured: 30 minutes post-administration

  5. Side effects

    The patients will be assessed every 15 minutes for this outcome

    Measured: From the drug administration to 60 minutes afterward

  6. Nasal irritation

    Nasal irritation will be assessed using a 3-level Likert-like scale, ranging from 1 to 3, where 1 = no nasal irritation, 2 = mild nasal irritation, and 3 = severe nasal irritation. Higher scores indicate greater nasal irritation (worse outcome).

    Measured: 60 minutes after the drug administration

  7. Patient satisfaction score

    Patients will be asked to rate their satisfaction using a 5-level Likert-like scale, ranging from 1 to 5, where 1 = very dissatisfied and 5 = very satisfied. Higher scores indicate greater satisfaction (better outcome).

    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.

  1. First posted11 Sep 2026
  2. Study start10 Oct 2026 (estimated)
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07816302
Sponsor's protocol ID
97269
Status last verified
Sep 2026
First submitted
6 Sep 2026
Last updated
16 Sep 2026
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 20mg intranasal ketorolac and 30mg Intranasal Ketorolac in people with Pain and Ketorolac, 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 27 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 16 Sep 2026. 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?

Pain score at 30 minutes (time frame: 30 minutes post-administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07816302.

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 16 Sep 2026.

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