Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department
NCT ID: NCT06395428
Last Updated: 2024-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
75 participants
INTERVENTIONAL
2024-07-09
2027-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Haloperidol
Haloperidol 5 mg IM haloperidol
Haloperidol
Intramuscular injection of drug
Ketoralac
Ketoralac 30 mg IM
Ketorolac Tromethamine
Intramuscular injection of drug
Interventions
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Haloperidol
Intramuscular injection of drug
Ketorolac Tromethamine
Intramuscular injection of drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presenting to the Bronson ED with a chief complaint of acute, non-traumatic back pain
* VAS score \>5 cm
Exclusion Criteria
* Experiencing saddle anesthesia
* Has bowel or bladder dysfunction
* Has an abnormal neurological exam
* Requires imaging in ED
* Has a Glascow coma score \<15
* Has one or more abnormal vital signs:
HR\>120, SBP\>180 or \<90, temperature \>38°, O2 saturation\<92%
* Has an allergy to ketorolac or haloperidol
* Has a known diagnosis of Lewy Body Dementia
* Has a known diagnosis of glaucoma.
* Is known to be pregnant or breastfeeding
* Is a prisoner or ward of the state
* Is unable to consent for themselves/ non-english speaking
* In the opinion of the attending physician or investigator the patient should not participate in the research
18 Years
65 Years
ALL
No
Sponsors
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Bronson Methodist Hospital
UNKNOWN
Western Michigan University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Jessica McCoy, MD
Role: PRINCIPAL_INVESTIGATOR
Western Michigan University Homer Stryker M.D. School of Medicine
Locations
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Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Silberstein SD, Peres MF, Hopkins MM, Shechter AL, Young WB, Rozen TD. Olanzapine in the treatment of refractory migraine and chronic daily headache. Headache. 2002 Jun;42(6):515-8. doi: 10.1046/j.1526-4610.2002.02126.x.
McCoy JJ, Aldy K, Arnall E, Petersen J. Treatment of Headache in the Emergency Department: Haloperidol in the Acute Setting (THE-HA Study): A Randomized Clinical Trial. J Emerg Med. 2020 Jul;59(1):12-20. doi: 10.1016/j.jemermed.2020.04.018. Epub 2020 May 10.
Todd KH, Ducharme J, Choiniere M, Crandall CS, Fosnocht DE, Homel P, Tanabe P; PEMI Study Group. Pain in the emergency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. J Pain. 2007 Jun;8(6):460-6. doi: 10.1016/j.jpain.2006.12.005. Epub 2007 Feb 15.
Edwards J, Hayden J, Asbridge M, Gregoire B, Magee K. Prevalence of low back pain in emergency settings: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Apr 4;18(1):143. doi: 10.1186/s12891-017-1511-7.
Kea B, Fu R, Lowe RA, Sun BC. Interpreting the National Hospital Ambulatory Medical Care Survey: United States Emergency Department Opioid Prescribing, 2006-2010. Acad Emerg Med. 2016 Feb;23(2):159-65. doi: 10.1111/acem.12862. Epub 2016 Jan 23.
Hoppe JA, Kim H, Heard K. Association of emergency department opioid initiation with recurrent opioid use. Ann Emerg Med. 2015 May;65(5):493-499.e4. doi: 10.1016/j.annemergmed.2014.11.015. Epub 2014 Dec 18.
Ruhm CJ. Geographic Variation in Opioid and Heroin Involved Drug Poisoning Mortality Rates. Am J Prev Med. 2017 Dec;53(6):745-753. doi: 10.1016/j.amepre.2017.06.009. Epub 2017 Aug 7.
Bertrand S, Meynet G, Taffe P, Della Santa V, Fishman D, Fournier Y, Frochaux V, Ribordy V, Rutschmann OT, Hugli O. Opiophobia in Emergency Department Healthcare Providers: A Survey in Western Switzerland. J Clin Med. 2021 Mar 25;10(7):1353. doi: 10.3390/jcm10071353.
Gueant S, Taleb A, Borel-Kuhner J, Cauterman M, Raphael M, Nathan G, Ricard-Hibon A. Quality of pain management in the emergency department: results of a multicentre prospective study. Eur J Anaesthesiol. 2011 Feb;28(2):97-105. doi: 10.1097/EJA.0b013e3283418fb0.
Duncan RW, Smith KL, Maguire M, Stader DE 3rd. Alternatives to opioids for pain management in the emergency department decreases opioid usage and maintains patient satisfaction. Am J Emerg Med. 2019 Jan;37(1):38-44. doi: 10.1016/j.ajem.2018.04.043. Epub 2018 Apr 22.
Rech MA, Griggs C, Lovett S, Motov S. Acute pain management in the Emergency Department: Use of multimodal and non-opioid analgesic treatment strategies. Am J Emerg Med. 2022 Aug;58:57-65. doi: 10.1016/j.ajem.2022.05.022. Epub 2022 May 22.
Verdu B, Decosterd I, Buclin T, Stiefel F, Berney A. Antidepressants for the treatment of chronic pain. Drugs. 2008;68(18):2611-32. doi: 10.2165/0003495-200868180-00007.
Kroeze WK, Hufeisen SJ, Popadak BA, Renock SM, Steinberg S, Ernsberger P, Jayathilake K, Meltzer HY, Roth BL. H1-histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs. Neuropsychopharmacology. 2003 Mar;28(3):519-26. doi: 10.1038/sj.npp.1300027.
Kiser RS, Cohen HM, Freedenfeld RN, Jewell C, Fuchs PN. Olanzapine for the treatment of fibromyalgia symptoms. J Pain Symptom Manage. 2001 Aug;22(2):704-8. doi: 10.1016/s0885-3924(01)00302-5.
Seidel S, Aigner M, Ossege M, Pernicka E, Wildner B, Sycha T. Antipsychotics for acute and chronic pain in adults. J Pain Symptom Manage. 2010 Apr;39(4):768-78. doi: 10.1016/j.jpainsymman.2009.09.008. Epub 2010 Mar 11.
Inayat F, Virk HU, Ullah W, Hussain Q. Is haloperidol the wonder drug for cannabinoid hyperemesis syndrome? BMJ Case Rep. 2017 Jan 4;2017:bcr2016218239. doi: 10.1136/bcr-2016-218239.
Cowling M, Covington S, Roehmer C, Musey P. Characterizing the role of haloperidol for analgesia in the Emergency Department. J Pain Manag. 2019;12(2):141-146.
Related Links
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Haloperidol by Patriot Pharmaceuticals LLC / Johnson \& Johnson Research \& Development, LLC / Janssen Pharmaceutica NV / Janssen Pharmaceutica, NV HALOPERIDOL injection.
Other Identifiers
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WMed-2024-1032
Identifier Type: -
Identifier Source: org_study_id
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