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Nasal spray painkiller: can a higher dose work better in the ER?

NCT ID NCT07816302

Symptom relief Sponsor: Tehran University of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

Researchers are testing whether a 30 mg dose of ketorolac given as a nasal spray relieves acute pain as well as a 20 mg dose in adults who arrive at the emergency department with moderate to severe pain. The trial enrolls 100 people aged 18 to 65 who weigh more than 50 kg and have had pain for less than 48 hours. Participants receive one of the two doses through a mucosal atomizer, and researchers measure pain scores at 15, 30, and 45 minutes to compare effectiveness and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), given as a nasal spray
What this could lead to
If the higher dose works as well as the lower dose, emergency departments could use a simple nasal spray to relieve acute pain without an IV line.
What could go wrong
This is a small, single-center trial of 100 people, so the results may not apply to everyone. Ketorolac can cause stomach bleeding, kidney problems, and allergic reactions, and it is not safe for people with ulcers, kidney failure, or NSAID allergies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

Emergencies Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intranasal drug administration Ketorolac Pain

How to take part

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  1. The official record

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