A Phase 3 interventional study of 20mg intranasal ketorolac and 30mg Intranasal Ketorolac in Pain, Ketorolac and Intranasal Drug Administration, sponsored by Tehran University of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Tehran University of Medical Sciences · Phase 3, Interventional, and Treatment
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 100 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Tehran University of Medical Sciences is the lead sponsor of 231 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril
Drug: 30mg Intranasal Ketorolac
30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril.
Drug: 20mg intranasal ketorolac
20 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril
30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril
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)
Time frame: 30 minutes post-administration
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)
Time frame: 15 minutes post-administration
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)
Time frame: 45 minutes post-administration
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)
Time frame: 60 minutes post-administration
Need for rescue analgesia
IV morphine 0.1 mg/kg will be available at 30 minutes in cases of patients request
Time frame: 30 minutes post-administration
Side effects
The patients will be assessed every 15 minutes for this outcome
Time frame: From the drug administration to 60 minutes afterward
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).
Time frame: 60 minutes after the drug administration
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).
Time frame: 60 minutes after the drug administration
No study locations are listed for this record.
Plan to share: No — The information is not allowed to be shared.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketorolac
Tehran University of Medical Sciences →