ketorolac intranasal (ROX 828) / Daiichi Sankyo - LARVOL DELTA

Efficacy and safety of intranasal agents for the acute treatment of migraine: a systematic review and network meta-analysis. (PubMed, J Headache Pain) - "Compared with other new intranasal-specific therapies in treating migraine attacks, zolmitriptan nasal spray 5 mg was the most effective agent for pain freedom at 2 h. Zavegepant nasal spray 10 mg had the fewest adverse side effects."

Journal • Retrospective data • Review • CNS Disorders • Migraine • Pain

Ink-Arc: Atomized Intranasal Vs Intravenous Ketorolac in Acute Renal Colic Pain Management. (clinicaltrials.gov) - P2/3; N=150; Recruiting; Sponsor: Oman Medical Speciality Board; Not yet recruiting ➔ Recruiting; Trial completion date: Sep 2021 ➔ Dec 2021; Initiation date: Sep 2020 ➔ Dec 2020; Trial primary completion date: Sep 2021 ➔ Dec 2021

Clinical • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Pain

Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children (clinicaltrials.gov) - P3; N=80; Recruiting; Sponsor: Columbia University; Trial completion date: Jun 2020 ➔ Jun 2021; Trial primary completion date: Jun 2020 ➔ Jun 2021

Clinical • Head-to-Head • Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

Atomized intranasal vs intravenous fentanyl in severe renal colic pain management: A randomized single-blinded clinical trial. (PubMed, Am J Emerg Med) - "Fentanyl is highly effective in controlling pain in patients with severe renal colic referring to the emergency department. Intranasal administration of fentanyl combination with ketorolac can be an appropriate, non-invasive, easy-to-use and fast alternative to the intravenous method to manage pain in these patients."

Clinical • Journal • Pain • Renal Calculi • Urolithiasis

Sprix for Postoperative Pain Control Following Gynecologic Surgery (clinicaltrials.gov) - P4; N=90; Not yet recruiting; Sponsor: University of Louisville

New P4 trial • Pain • Urinary Incontinence

Ink-Arc: Atomized Intranasal Vs Intravenous Ketorolac in Acute Renal Colic Pain Management. (clinicaltrials.gov) - P2/3; N=150; Not yet recruiting; Sponsor: Oman Medical Speciality Board

Clinical • New P2/3 trial • Pain

Factors Associated With Discharge After Initial Emergency Treatment of Pediatric Migraine. (PubMed) - "Arrival pain score may be used to help select initial migraine treatment in the pediatric ED. Initial use of PO/IN regimens including triptans or an antiemetic and concurrent administration of IV ketorolac with an antiemetic may be associated with higher rates of discharge after initial treatment alone."

Journal • Biosimilar • Migraine • Pain

An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain (clinicaltrials.gov) - P=N/A; N=30; Active, not recruiting; Sponsor: The Cleveland Clinic; Trial primary completion date: Apr 2013 ->Jun 2012

Trial primary completion date • Biosimilar • Pain

NON IGE-MEDIATED ASPIRIN INDUCED ANAPHYLAXIS IN A PATIENT WITH ASPIRIN EXACERBATED RESPIRATORY DISEASE (ACAAI 2019) - "Case Description A 69 year-old woman with three prior polypectomies underwent aspirin IDT without the use of intranasal ketorolac at an outside facility three years prior. Discussion Non IgE-mediated anaphylaxis secondary to aspirin is possible. Omalizumab and zilueton as pre-medications for aspirin IDT may be of use for this particular sub-population of AERD patients."

Clinical • Tryptase

AN “EXCEPTIONAL” ASPIRIN-EXACERBATED RESPIRATORY DISEASE PATIENT (ACAAI 2019) - "During desensitization, at the highest dose of intranasal ketorolac (7.58 mg), he developed progressive severe abdominal pain, laryngeal symptoms, asthma and nasal symptoms. In seven years, he has had no further polyp regrowth, and has maintained good control of his asthma with a daily aspirin and controller inhaler. Discussion This case highlights the heterogeneity within the AERD population and emphasizes the point: Although this patient had exceptionally difficult desensitization, his dramatic response to aspirin therapy highlights the important role this therapy can have in AERD."

Clinical

Comparison of analgesic effects of intravenous and intranasal ketorolac in patients with mandibular fracture-A Randomized Clinical Trial. (PubMed, J Clin Exp Dent) - "Application of intranasal ketorolac spray decreased pain after mandibular fracture surgery, especially at 8-hour interval after surgery, decreasing the need for opioids. Key words:Ketorolac, intranasal, intravenous, mandibular fracture."

Clinical • Journal

Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children (clinicaltrials.gov) - P3; N=80; Recruiting; Sponsor: Columbia University; Trial completion date: Dec 2019 ➔ Jun 2020; Trial primary completion date: Dec 2019 ➔ Jun 2020

Clinical • Head-to-Head • Trial completion date • Trial primary completion date

Nasal challenge with ketorolac: utility and safety in clinical practice (AAAAI 2019) - "Rationale: Nasal ketorolac challenge (NKC) has been proposed as a diagnosis test for patients with aspirin exacerbated respiratory disease (AERD) with predominantly nasal symptoms. NKC with 16.38mg is a useful method for diagnosis of AERD although it is not as safe in everyday clinical practice as previous publications."

Clinical

Pharmacokinetics of Intranasal Ketorolac in Children (clinicaltrials.gov) - P1; N=18; Terminated; Sponsor: Columbia University; Trial completion date: Dec 2018 ➔ Nov 2017; Recruiting ➔ Terminated; Trial primary completion date: Dec 2018 ➔ Nov 2017; Enrolment issues

Clinical • Trial completion date • Trial primary completion date • Trial termination