120 Participants Needed

Intranasal Ketorolac for Migraines

CL
Overseen ByCarlee Lenehan, MD
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if intranasal (IN) Ketorolac in combination with oral Prochlorperazine and Diphenhydramine is non-inferior to current migraine management which involves use of intravenous (IV) Ketorolac and oral adjuncts Prochlorperazine and diphenhydramine for reducing pain intensity in children with migraine headaches. The investigators hypothesize that IN ketorolac combined with these oral adjuncts is non-inferior to IV ketorolac and oral adjuncts in reducing acute migraine headache pain by a minimum clinically significant difference within 60 minutes of administration.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before participating. If you are taking NSAIDs (like ibuprofen) within six hours, or oral prochlorperazine, metoclopramide, or diphenhydramine within 12 hours, you cannot participate. Additionally, if you are on specific medications like antiplatelets, anticoagulants, or certain antidepressants, you will be excluded from the study.

What data supports the effectiveness of the drug for treating migraines?

Research shows that intranasal ketorolac, a drug used for pain relief, is effective in reducing migraine pain. In a study, 64% of patients experienced significant pain reduction after using ketorolac, and it helped decrease the need for emergency room visits.12345

Is intranasal ketorolac safe for humans?

Intranasal ketorolac has been shown to have a safety profile similar to other forms of administration, with no adverse effects on the nasal passages or respiratory system in animal studies. It has also been used safely in humans for pain management, including in patients with migraines and postoperative pain.12467

How is the drug ketorolac unique for treating migraines?

Intranasal ketorolac (SPRIX) is unique for treating migraines because it combines ketorolac, a non-opioid pain reliever, with lidocaine, a numbing agent, and is administered through the nose, offering a non-injection, non-oral option that can be quickly absorbed and effective for acute migraine relief.12489

Research Team

CL

Carlee Lenehan, MD

Principal Investigator

Washington University in St. Louis: st. louis childrens hospital

Eligibility Criteria

This trial is for children with migraines that are moderate to severe, affect daily activities, have specific characteristics like pulsating pain or nausea, and last between 1 to 72 hours. Participants must rate their pain at least 4/10 on the Faces Pain Scale.

Inclusion Criteria

My headache matches at least three of the listed features.
My pain level is at least 4 out of 10.
My headaches last between 1 and 72 hours.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either intranasal ketorolac with oral adjuncts or intravenous ketorolac with oral adjuncts to manage migraine pain

Single session
1 visit (in-person)

Follow-up

Participants are monitored for changes in pain intensity using the Faces Pain Scale - Revised at multiple time points after treatment

2 hours
1 visit (in-person)

Treatment Details

Interventions

  • Diphenhydramine
  • Ketorolac
  • Prochlorperazine
Trial OverviewThe study tests if nasal spray Ketorolac combined with oral Prochlorperazine and Diphenhydramine is as effective as IV Ketorolac for reducing migraine pain in kids within an hour of taking it.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intranasal PatientsExperimental Treatment3 Interventions
Intranasal ketorolac (1 spray (15.75mg) if 15kg-29.9kg and 2 sprays (31.5mg) if 30kg or heavier and oral adjuncts oral Prochlorperazine (Between 15-25 kg: dose of 2.5 mg; 26-50 kg: dose of 5 mg; \> 50 kg: dose of 10 mg, single maximum dose 10 mg) and oral Diphenhydramine (Between 15-25 kg: dose of 12.5 mg; 26-50 kg: dose of 25 mg; \> 50 kg: dose of 50 mg, single maximum dose 50mg)
Group II: Intravenous PatientsActive Control3 Interventions
IV ketorolac (0.5 mg/kg, maximum single dose of 30 mg) with oral adjuncts oral Prochlorperazine (Between 15-25 kg: dose of 2.5 mg; 26-50 kg: dose of 5 mg; \> 50 kg: dose of 10 mg, single maximum dose 10 mg) and oral Diphenhydramine (Between 15-25 kg: dose of 12.5 mg; 26-50 kg: dose of 25 mg; \> 50 kg: dose of 50 mg, single maximum dose 50mg)

Ketorolac is already approved in United States, European Union, Switzerland for the following indications:

🇺🇸
Approved in United States as Toradol for:
  • Moderate to severe pain
  • Postoperative pain
  • Dysmenorrhea
  • Idiopathic pericarditis
  • Ocular itching
🇪🇺
Approved in European Union as Toradol for:
  • Moderate to severe pain
  • Postoperative pain
  • Dysmenorrhea
🇺🇸
Approved in United States as Acular for:
  • Ocular itching
  • Inflammation after eye surgery
🇺🇸
Approved in United States as Sprix for:
  • Moderate to severe pain
🇨🇭
Approved in Switzerland as Ketorolac for:
  • Moderate to severe pain
  • Postoperative pain

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Assertio Holdings, Inc

Collaborator

Trials
1
Recruited
120+

Findings from Research

The intranasal formulation of ketorolac tromethamine, known as SPRIX, provides a similar pharmacokinetic profile to intramuscular administration, making it an effective option for treating moderately severe acute pain.
Toxicology studies in rats and rabbits indicate that SPRIX has a safety profile comparable to other administration routes, with no adverse effects observed on the nasal passages or respiratory system.
A novel formulation of ketorolac tromethamine for intranasal administration: preclinical safety evaluation.Boyer, KC., McDonald, P., Zoetis, T.[2013]
In a trial involving 140 patients with moderate-to-severe migraines, the intranasal formulation of ketorolac tromethamine (ROX-828) showed significant improvements in pain relief compared to placebo at multiple time points, although it did not meet the primary endpoint at two hours.
ROX-828 was well tolerated, with nasal discomfort being the most common side effect, and it also significantly improved associated migraine symptoms like nausea and sensitivity to light and sound.
Intranasal ketorolac tromethamine (SPRIX(R)) containing 6% of lidocaine (ROX-828) for acute treatment of migraine: safety and efficacy data from a phase II clinical trial.Pfaffenrath, V., Fenzl, E., Bregman, D., et al.[2013]
In a multicenter study involving patients with moderate to severe inflammation after cataract surgery, ketorolac tromethamine 0.5% was significantly more effective than a placebo in reducing inflammation and associated symptoms like pain and photophobia.
The treatment was found to be safe, with no significant differences in visual acuity or adverse events compared to the placebo, indicating that ketorolac is a reliable option for managing post-surgical inflammation.
Ketorolac tromethamine 0.5% ophthalmic solution in the treatment of moderate to severe ocular inflammation after cataract surgery: a randomized, vehicle-controlled clinical trial.Heier, J., Cheetham, JK., Degryse, R., et al.[2019]

References

A novel formulation of ketorolac tromethamine for intranasal administration: preclinical safety evaluation. [2013]
Intranasal ketorolac tromethamine (SPRIX(R)) containing 6% of lidocaine (ROX-828) for acute treatment of migraine: safety and efficacy data from a phase II clinical trial. [2013]
Ketorolac tromethamine 0.5% ophthalmic solution in the treatment of moderate to severe ocular inflammation after cataract surgery: a randomized, vehicle-controlled clinical trial. [2019]
Self-administration of parenteral ketorolac tromethamine for head pain. [2019]
A randomized, double-blind, comparative study of the efficacy of ketorolac tromethamine versus meperidine in the treatment of severe migraine. [2019]
Intracranial hemorrhage requiring surgery in neurosurgical patients given ketorolac: a case-control study within a cohort (2001-2010). [2022]
The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. [2013]
Pulmonary and nasal deposition of ketorolac tromethamine solution (SPRIX) following intranasal administration. [2018]
The pharmacokinetics of ketorolac after single postoperative intranasal administration in adolescent patients. [2013]